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| Name | Class |
|---|---|
| The University of Western Australia | OTHER |
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Recently, controversy has emerged regarding the role of the 23vPPV in infants due to potential immunological hypo-responsiveness (i.e. a poorer immune response to repeat vaccination). Although previous experience of 23vPPV in children in PNG has demonstrated protective efficacy against acute lower respiratory tract infection, the investigators feel it is a matter of urgency to determine if 23vPPV administration provides elevated antibody concentrations at 3 to 5 years of age, and to ensure the immunological safety of the 23vPPV in infants.
Following consent and eligibility assessment, a baseline blood sample and nose swab will be taken, a 0.1ml dose of 23vPPV will be administered and a follow up blood sample and nose swab will be collected 28 days later. The investigators will also collect data on incidence of ALRI in all study participants by medical record review.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neonatal PCV + PPV 9 months | Active Comparator | Group 1: Children receiving 7VPCV at 0-1-2 months of age and PPV at 9 months of age |
|
| Infant PCV + PPV at 9 months | Active Comparator | Group 2: Children receiving 7VPCV at 1-2-3 months of age and PPV at 9 months of age |
|
| No PCV + PPV at 9 months | Active Comparator | Group 3: Children who only received PPV at 9 months of age |
|
| Control | Active Comparator | Group 4: Children who have not received any previous pneumococcal vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prevenar + PPV | Biological | 0.5mL dose of Prevenar at 0-1-2 months, 0.5mL Pneumovax at 9 months and 0.1mL Pneumovax at 3-5 yrs |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure serotype-specific antibody persistence in children aged 3-5 years after vaccination with 23vPPV at 9 months of age and compared to unvaccinated controls. | Children who were previously vaccinated with Pneumovax (23vPPV) at 9 months will be followed up at age 3-5 years of age. They will be given a challenge dose of Pneumovax (0.1mL) and followed up 1 months later. Age matched controls identified from each villages will also be recruited and given a challenge dose of Pneumovax. Serotype-specific antibodies will be measure pre- and post-challenge dose to determine anitbody levels. | 2yrs |
| Measure | Description | Time Frame |
|---|---|---|
| Measure the number of circulating serotype-specific memory B-cells pre- & post- booster immunisation | 2yrs | |
| Measure nasopharyngeal pneumococcal serotype-specific carriage rates pre- and post- 23vPPV challenge dose | 2yrs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter C Richmond, MD | School of Paediatrics and Child Health, University of Western Australia | Principal Investigator |
| Deborah Lehmann, MSc | Telethon Institute for Child Health Research | Principal Investigator |
| William S Pomat, PhD | Papua New Guinea Institute of Medical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PNG Institute of Medical Research | Goroka | Eastern Highlands Province | 441 | Papua New Guinea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29028802 | Derived | van den Biggelaar AHJ, Richmond PC, Fuery A, Anderson D, Opa C, Saleu G, Lai M, Francis JP, Alpers MP, Pomat WS, Lehmann D. Pneumococcal responses are similar in Papua New Guinean children aged 3-5 years vaccinated in infancy with pneumococcal polysaccharide vaccine with or without prior pneumococcal conjugate vaccine, or without pneumococcal vaccination. PLoS One. 2017 Oct 13;12(10):e0185877. doi: 10.1371/journal.pone.0185877. eCollection 2017. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 24, 2014 | |
| Reset | Aug 13, 2014 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 24, 2014 | Aug 13, 2014 |
| ID | Term |
|---|---|
| D000069443 | Heptavalent Pneumococcal Conjugate Vaccine |
| D011237 | Predictive Value of Tests |
| ID | Term |
|---|---|
| D022242 | Pneumococcal Vaccines |
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
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| Infant PCV (Prevenar) + PPV at 9 months | Biological | 0.5mL Prevenar at 1-2-3 months,0.5mL Pneumovax (PPV) at 9 months, 0.1mL Pneumovax at 3-5 yrs |
|
|
| No Prevenar + PPV at 9 months | Biological | no Prevenar, 0.5mL Pneumovax at 9 months, 0.1mL Pneumovax at 3-5 yrs |
|
| Control | Biological | control, 0.1mL Pneumovax at 3-5yrs |
|
| D001688 |
| Biological Products |
| D045424 | Complex Mixtures |
| D017778 | Vaccines, Combined |
| D012680 | Sensitivity and Specificity |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |