1. Operational GuidelinesPentavalent VaccineIntroduction(DPT+HepB+Hib)Theforce offive inone

2. Operational GuidelinesHib-containing Pentavalent Vaccine in theUniversal Immunization Programme2014Operational guidelines developed by theWHOCountry Office for India for Ministry of Health &FamilyWelfare, Government of India 3. CONTENTS1. Background.............................................................................................................. 12. The disease - Haemophilus influenzaetype b........................................................... 5Frequently asked questions - Haemophilus influenzaetype b.................................. 83. Hib-containing pentavalent vaccine......................................................................... 114. Programme-level actions and decisions to be taken................................................ 175. Steps for the inclusion of pentavalent vaccine in the Universal ImmunizationProgramme in India.................................................................................................. 256. Monitoring and supervision...................................................................................... 377. Frequently asked questions - Hib-containing pentavalent vaccine.......................... 431. Key findings and recommendations of post-introduction evaluation (PIE)of pentavalent vaccine in India.................... 452. Pentavalent vaccine training workshop for medical officers atstate/district level....................................................................................................... 483. Pentavalent vaccine training workshop for data handlers at state/district level........ 514. Pentavalent vaccine training workshop for vaccine and cold chain handlers atstate/district level........ 545. Pentavalent vaccine training workshop for ANMs, LHVs and healthsupervisors at block level.......... 576. Pentavalent vaccine training workshop for ASHAs/AWWs/link workers atblock level 617. 64Pentavalent vaccine Training workshop for iec/media Handling focal persons.................. 66AnnexuresReferences 4. ACRONYMS 5. 1. BACKGROUNDPentavalent Vaccine in UIP(5 antigens)DPT + Hepatitis B + HibThe force of five in one1Dont Forget,accination VYour baby must get! 6. Fig. 1. Pentavalent vaccine introduction in states with support from GoIPentavalent vaccine introduction and scale upPentavalent vaccine introduction - 8 StatesPentavalent vaccine proposed in 2014 - 12 states2S.No.Pentavalent introductionplanned in 2014Andhra PradeshTelanganaAssamBiharChattisgarhDelhiJharkhandMadhya PradeshPunjabRajasthanUttarakhandWest Bengal123456789101112 7. 3Dont Forget,accination VYour baby must get! 8. 2. THE DISEASEHAEMOPHILUS INFLUENZAE TYPE B (Hib)5Dont Forget,accination VYour baby must get! 9. 6 10. 7Dont Forget,accination VYour baby must get! 11. Frequently asked questions Haemophilus influenzae type b8 12. 9Dont Forget,accination VYour baby must get! 13. LiquidVaccine5ml10 dosevialDPT + Hep B + HibVVM3. Hib-CONTAININGPENTAVALENT VACCINE11Dont Forget,accination VYour baby must get! 14. Table 1. Immunization schedulecurrent and post-pentavalent introductionAge Current immunizationschedule (Prior topentavalent introduction)Immunization schedule(post pentavalentintroduction)RemarksAt birth BCG, OPV (0 dose), hepati- BCG, OPV (0 dose),Hepatitis B (birth dose) hepatitis B (birth dose)12to 1 year of age(2) DPT vaccinecan be givenup to 56 years(not beyond 7years) of age(3) Measlesvaccine canbe given up to5 years of age(4) JE vaccine canbe given up to 15years of age.6 weeks(1 months )OPV-1, DPT-1, hepatitis B-1 OPV-1, pentavalent-110 weeks(2 months )OPV-2, DPT-2, hepatitis B-2 OPV-2, pentavalent -214 weeks(3 months )OPV-3, DPT-3, hepatitis B-3 OPV-3, pentavalent -39 months Measles first dose, JE-1(where applicable)Measles first dose, JE-1(where applicable)1624 months DPT-booster first dose,measles second dose, OPVbooster dose , JE seconddose (where applicable)DPT-booster first dose,measles second dose,OPV booster dose, JEsecond dose (whereapplicable)56 years DPT-booster second dose DPT-booster second dose10 years TT first booster dose TT first booster dose16 years TT second booster dose TT second booster dose(1) BCG vaccinecan be given up 15. 13Dont Forget,accination VYour baby must get! 16. 14RememberOpen Vial Policy not applicable toMeasles BCG JEMeasles BCG JE 17. 15Dont Forget,accination VYour baby must get! 18. 4. PROGRAMME-LEVELACTIONS ANDDECISIONS TO BE TAKEN17Dont Forget,accination VYour baby must get! 19. RememberA maximum of 15 % wastage isacceptable for Pentavalent andall other vaccines that are eligiblefor reuse as per open vial policyguidelines.18 20. M6 M1019Dont Forget,accination VYour baby must get!Fig. 2. Reporting pentavalent vaccine coverage in the HMISCHILD IMMUNIZATIONNumber of Infants 0 to 11 months old who received the followingBCGDPT1DPT2DPT3Pentavalent 1Pentavalent 2Pentavalent 3OPV 0 (Birt Dose)OPV 1OPV 2OPV 32222.122.222.322.422.4A22.4B22.4C22.522.622.722.810.110.1.0110.1.0210.1.0310.1.0410.1.04A10.1.04B10.1.04C10.1.0510.1.0610.1.0710.1.08 21. Fig. 3. Reporting pentavalent vaccine coverage in the MCTS20 22. 21Dont Forget,accination VYour baby must get! 23. 22 24. Four key messages for caregivers What vaccine was given and what diseases it prevents When and where to come for the next visit What minor adverse events could occur and how todeal with them Keep the immunization card safe and bring it along atthe next visit.23Dont Forget,accination VYour baby must get! 25. 5. STEPS FOR THEINCLUSION OF PENTAVALENTVACCINE IN THE UIP IN INDIA25Dont Forget,accination VYour baby must get! 26. Table 2.Checklist components261. Human resourcevitals2. Backgroundinformation3. Microplanning status 4. Training status5. Reporting andrecording practices6. Vaccine coverageand wastage7. Vaccine management,transport and logistics8. Waste managementand injection safety9. Monitoring andevaluation10. AEFI 11. Mobilization12. Advocacy andcommunication13. Surveillance14. Cold chainmaintenance15. General impressions16. Additional remarks/comments 27. Table 3. State-level training workshops/TOTs27TimelineWithin 3weeks aftercompletionof nationallevelworkshopTrainees Trainers DurationData handlers: District levelHMIS and MCTS coordinators,district computer assistant toDIOs, District M and E focalperson (NRHM), focal personresponsible for immunizationreports in CMO office (districts toidentify and nominate least 3persons per district)State ImmunizationOfficer (SIO), StateHMIS and MCTScoordinator, State Mand E focalperson/coordinator,representatives frompartner organizationssuch as WHO,UNICEF and othersOne day foreachworkshopS.No.2.Mos: DIO and 2 MOs per district(3 persons per district). Alsoinclude SMOs of WHO NPSP ,UNICEF district coordinators, andothers such as State ProgrammeManager (NRHM), State IECConsultant, State ASHACoordinator, State Cold ChainOfficer, State Data Manager,State M and E Coordinator(NRHM), State Finance andAccounts manager (NRHM)SIO with support fromState CCO, HMIS andMCTS coordinators,IEC consultant andpartners WHONPSP,UNICEF, others1.Dont Forget,accination VYour baby must get!2. 28. S.No. Trainees Trainers Duration Timeline28Vaccine and cold chain handlers:District refrigerator mechanic,vaccine storekeeper in charge ofimmunization programme atdistrict level (at least 2 personsper district)State Immunizationofficer (SIO), Statecold chain officer(CCO),representatives frompartner organizationssuch as WHO,IEC/media handling focalpersons: Districts to identify andnominate at least 2 personsdealing with media and IEC forsensitization at state levelSIO with support fromWHO, UNICEF andother partners, StateIEC consultant, mediaofficer, partnersOne day foreachworkshop3.4.Pentavalent vaccine advocacyand launch: Workshop for keystate/ district officials,development partners includingmedia (print/ electronic)SIO with support fromWHO, UNICEF andother partners, StateIEC Consultant, mediaofficer, partners. PS tochair and MD NRHMto co-chair. Directorsand all CMOs shouldbe presentAfter thenationallevelworkshop(at least2 weeksprior to thelaunch)5. 29. 29Dont Forget,accination VYour baby must get! 30. 30 31. Table 4. Summary of district training workshops/TOTsS.No Trainees Trainers Duration TimelineNotes: 1. Refer to Annexures 2, 3 and 4 for agenda and tips for trainers for Serials 1, 2 and 3respectively.2. Submit fortnightly progress on training status of each level of functionaries to the State ImmunizationOfficer.311.Master trainers: DIOand 2 MOs trained atstate level.Include HMIS andMCTS staff trained atstate level.Master trainers: DIOand 2 MOs trained atstate level along withdistrict cold chainhandler, refrigeratormechanic trained atstate levelDIO with support fromWHO, UNICEF andother partners, districtIEC consultant, mediaofficer, partnersDIO with support fromWHO, UNICEF andother partners, districtIEC consultant, mediaofficer. DM to chairOne day foreachworkshopWithin 2weeks aftercompletionof state-levelworkshopWithin 3weeks aftercompletionof state-levelworkshopAt least 2weeks priorto thelaunch2.3.4.5.Data handlers: Block/planningunit to identify and nominate atleast 2 data handlers involved inimmunization data entry (HMISand MCTS data)perblock/planning unit. Nominationto be forwarded to DIOVaccine and cold chainhandlers: Block/planning unit toidentify and nominate at least 2persons per vaccine storagepoint. Nominations to beforwarded to DIOIEC/media handling focalpersons: Blocks to identify andnominate at least one persondealing with media and IEC.Nominations to be forwarded toDIOPentavalent advocacy andlaunch: Workshop for keydistrict/block officials,development partners includingmedia (print/electronic). DIO withsupport of partners to prepare theagenda and list of invited officialsMaster trainers: DIOand 2 MOs trained atstate levelMos: Blocks to identify andnominate the names of at least 2MOs per block/urban planningunit. Nominations to be forwardedto DIO. Others include DistrictProgramme Manager NRHM,District IEC Consultant, DistrictASHA Coordinator, District ColdChain Handler, District DataManager, District M and ECoordinator (NRHM), DistrictAccounts Manager (NRHM)Dont Forget,accination VYour baby must get! 32. 32 33. Table 5. Block-level training workshops/TOTsS.No Trainees Trainers Duration Timeline1. Health workers (ANMs, LHVs,33health SupervisorsDistrict and blockmaster trainers(DIO and 2 MOs trainedat state level + 2 blocklevel MOs trained atdistrict level).They will be supportedby other trained officialssuch as district/blocklevel data handlers,district vaccine and coldchain handler andothersOne day foreachworkshopWithin 3weeks ofcompletionof thedistrict-levelworkshop2.Mobilizers (ASHAs and AWWs)District and blockmaster trainersDIO and 2 MOs trainedat state level + 2 blocklevel MOs trained atdistrict level.They will be supportedby other trained officialssuch ASHAcoordinators at thedistrict level and othersDont Forget,accination VYour baby must get! 34. 34 35. 6. SUPERVISION ANDMONITORING37Dont Forget,accination VYour baby must get! 36. 38 37. 39Dont Forget,accination VYour baby must get! 38. 40 39. 41Dont Forget,accination VYour baby must get! 40. 7. FREQUENTLY ASKEDQUESTIONS - Hib - CONTAININGPENTAVALENT VACCINE43Dont Forget,accination VYour baby must get! 41. 44 42. ANNEXURE 1KEY FINDINGS AND RECOMMENDATIONSOF POST-INTRODUCTION EVALUATION (PIE)OF PENTAVALENT VACCINE IN INDIA45Dont Forget,accination VYour baby must get! 43. 46 44. 47Dont Forget,accination VYour baby must get! 45. ANNEXURE 2PENTAVALENT VACCINETRAINING WORKSHOP FOR MEDICALOFFICERS AT STATE/DISTRICT LEVELTable 1. Pentavalent vaccine training workshop for medical officersAgenda for pentavalent vaccine training workshop for medical officersTime Activity Person/s responsibleNote: Person/s responsible for conducting training to be decided at the local level48Total time: 6 hoursRegistration15 min Objectives of the workshop and opening remarks15 min Basic facts about pentavalent vaccine20 min Current and revised vaccination schedule20 min Concept of phasing in, phasing out andrepositioning of vaccine15 min Introduction to the immunization component of theMCP card /counterfoil and its use through tracking bag20 min Understanding full immunization and completeimmunization30 min Use of coverage monitoring chart, includingdemonstration of the tool.30 min Update on revised data entry tools and logisticrequirements (MCP cards, tally sheets, MCHregisters, HMIS/MCTS formats)15 min Entry of pentavalent vaccine in HMIS and MCTSportals20 min Coverage trends after pentavalent vaccineIntroduction, and actions required20 min National Cold Chain Management InformationSystem(NCCMIS) status20 min FAQs on pentavalent vaccine20 min Vaccine safety (AEFI) and immunization wastemanagement30 min What to do after this workshop: role in sensitizingthe health workforce15 min Interaction about way forwardWrap up 46. 49Dont Forget,accination VYour baby must get! 47. 50 48. ANNEXURE 3PENTAVALENT VACCINETRAINING WORKSHOP FOR DATAHANDLERS AT STATE/DISTRICT LEVELTable 2. Pentavalent vaccine training workshop for data handlersAgenda for pentavalent vaccine training workshop for data handlersTime Activity Person/s responsibleNote: Person/s responsible for conducting training to be decided at the local level51Total time: 6 hoursRegistration15 min Objective of the workshop and opening remarks15 min Basic facts about pentavalent vaccine20 min Current and revised vaccination schedule20 min Concept of phasing in, phasing out andrepositioning of vaccine20 min Understanding full immunization and completeimmunization30 min Use of coverage monitoring chart. Demonstrate toolfor analysis30 min Update on revised data entry tools and logisticrequirements (MCP cards, tally sheet, MCH registers,HMIS / MCTS formats)15 min Entry of pentavalent vaccination in HMIS and MCTSportals20 min Coverage trends after pentavalent vaccineintroduction, and actions required15 min Assessing immunization performance: physical andfinancial15 min NCCMIS status15 minFAQs on pentavalent vaccine30 min What to do after this workshop: role in training thedata handlersWrap upDont Forget,accination VYour baby must get! 49. 52 50. 53Dont Forget,accination VYour baby must get! 51. ANNEXURE 4PENTAVALENT VACCINE TRAININGWORKSHOP FOR VACCINE ANDCOLD CHAIN HANDLERS ATSTATE/DISTRICT LEVELTable 3. Pentavalent vaccine training workshop forvaccine and cold chain handlersAgenda for pentavalent vaccine training workshopvaccine and cold chain handlersNote: Person/s responsible for conducting training to be decided at the local level54Person/s responsible 52. 55Dont Forget,accination VYour baby must get! 53. 56 54. ANNEXURE 5PENTAVALENT VACCINETRAINING WORKSHOP FOR ANMS,LHVS AND HEALTH SUPERVISORS ATBLOCK LEVELTable 4. Pentavalent vaccine training workshop for ANMs,LHVs and health supervisorsAgenda for pentavalent vaccine training workshop for ANMs,LHVs and health supervisorsTime Activity Person/s responsible57Total time: 6 hoursRegistration10 min Objectives of workshop and opening remarks20 min Basic facts about pentavalent vaccine20 min Current and revised vaccination schedule20 min FAQs on pentavalent vaccine30 min Introduction to the immunization component of the MCPcard. Filling and use of counterfoil and its use throughtracking bagUnderstanding full immunization and completeimmunization20 min Improving microplanning. Emphasize on including polioHRA as part of the microplan and estimation ofbeneficiaries concept30 min Use of immunization tracking bag and due list for tracking30 min Learning to make sub-centre level coverage monitoringchart. Ask participants to bring their annual target ofinfants and month-wise DPT 1 and DPT 3 dosecoverage for the past 6 months30 min Revised logistics update (registers/MCP cards/tallysheets, MCH registers, HMIS / MCTS formats/ IECmaterial)15 min Where does an ANM enter data for pentavalentvaccination in the HMIS and MCTS registers/formats?20 min Discuss about how coverage of DPT, hepatitis B andpentavalent vaccine will change when pentavalentvaccine is introducedDont Forget,accination VYour baby must get! 55. 15 min Importance of ensuring open vial policy for DPT,TT,hepatitis B and pentavalent vaccine is in place throughalternate vaccine delivery10 min Explain how monitoring will intensify for vaccinesdistribution and return of unused/partial vaccines on theday of immunization20 min Vaccine safety (AEFI) and immunization wastemanagement. Explain reporting/management guidelines30 min What to do after this workshop: their role in sensitizingthe social mobilizers: ASHAs and AWWsNote: Person/s responsible for conduct of training to be decided at the local level5815 min Interaction about way forwardWrap up 56. 59Dont Forget,accination VYour baby must get! 57. 60 58. ANNEXURE 6PENTAVALENT VACCINETRAINING WORKSHOP FORASHAS/AWWS/LINK WORKERSAT BLOCK LEVELTable 5. Pentavalent vaccine training workshop forASHAs/AWWs/link workersAgenda for pentavalent vaccine training workshopASHA, AWW and link workersTime Activity Person/s responsibleNote: Person/s responsible for conducting training to be decided at the local level61Total time: 6 hoursRegistration10 min Objectives of the workshop and opening remarks10 min Basic facts about pentavalent vaccine10 min Current and revised vaccination schedules30 min Introduction to the immunization component of theMCP card; filling and using the counterfoil and its usethrough tracking bag; understanding fullimmunization and complete immunization10 min Improving microplanning, emphasizing on estimationof beneficiaries by ASHAs/AWWs in theircatchment area30 min Use of immunization tracking bag and helping toprepare due lists for tracking10 min New IEC materials related to pentavalent vaccineand how to display them.10 min Explain to them as to how coverage of DPT, hepatitisB and pentavalent vaccine will change oncepentavalent vaccine is introduced30 min Key messages regarding pentavalent vaccine thatASHAs/AWWs must understand for improvingvaccine coverage in the field. Emphasize onpentavalent vaccine messages (less pricks, moreantigens force of five in one)15 min Interaction about way forwardWrap upDont Forget,accination VYour baby must get! 59. 62 60. 63Dont Forget,accination VYour baby must get! 61. ANNEXURE 7PENTAVALENT VACCINETRAINING WORKSHOP FOR IEC/MEDIAHANDLING FOCAL PERSONSTable 6. Pentavalent vaccine training workshop for IEC/mediahandling focal personsPentavalent vaccine training workshopIEC/media handling focal personsPerson/s responsible64Person/s responsibleTotal time: 6 hoursTime ActivityRegistration10 min Objectives of the workshop and opening remarksExpected role of the participants in the programme30 min Understanding immunization status at national, stateand district levelsExplain full immunization and completeimmunizationSituational analysis:- Current status (evaluated coverage : Annual HealthSurvey (AHS) or District Level Household Survey(DLHS); compare with the previous evaluatedcoverage; explain the progress with focus on districts- Status of high priority districts (RMNCH+A), blocksand groups (polio HRAs)- Current strengths and challenges in immunizationprogram at state and district level- Understanding the issues and efforts related to theunreached. Tagging of polio HRAs in RI microplan- Mobilization efforts, incentives available for ASHA20 min Status of state and district preparedness forpentavalent vaccine introduction (are districts/blocksready?)Key findings and state efforts to improve the gaps20 min Basic facts about pentavalent vaccineHow would current vaccination schedule change afterintroduction of pentavalent introduction? 62. 20 min Key FAQs (refer to operational guidelines):Note: Person/s responsible for training to be decided at the local level.65- Hib disease- Pentavalent vaccine20 min Additional questions that media/participants are likelyto raise. (Participants should be encouraged to askquestions; facilitator to note these questions on the flipchart and then address them one by one).20 min Increasing visibility of the RI program in state with afocus on pentavalent vaccine introduction.Demonstrate the new IEC prototypes along with stateinstructions20 min Role of media, (print, electronic and social) inpentavalent vaccine introduction. Disseminate statespecific instructions30 min Risk communication (basics for handling an AEFIcrisis refer MoH communication guidelines forbuilding vaccine confidence around AEFI)45 min How to write a press releaseEssentials of a press conferenceKey points to remember for conducting a pressconference including essential documents neededduring the conference30 min Existing mechanism to monitor RI programme instates. State-specific efforts to monitor the visibility ofRI in states. Discuss about any evaluation data (ifavailable)Monitoring state IEC/ behavior change communication(BCC) efforts. Discuss and disseminate relevantformats and process of data entry, if any. If it does notexist, plan to institutionalize the same20 min IEC/BCC: Issues/challenges that participants foreseein new vaccine introduction and practical solutions attheir level15 min Based on pentavalent operational guidelines:- Activities (training) planned to be completed beforevaccine introduction (who trains whom and at whatlevel)Explain the role of participants in:- training the IEC/media handling officials (at least 2per block/planning unit)- planning the launch of the workshop including themedia briefing, press release, etc.Wrap upDont Forget,accination VYour baby must get! 63. REFERENCES66 64. Operational guidelines developed by the WHO Country Office for Indiafor Ministry of Health & Family Welfare, Governments of India