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| Name | Class |
|---|---|
| Papua New Guinea Institute of Medical Research | OTHER_GOV |
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This is an observational study to determine the reactogenicity and immunogenicity of pneumococcal conjugate vaccine in non-pregnant women of reproductive age in Papua New Guinea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women of childbearing age | Healthy non-pregnant women between 18 and 45 years old living in Goroka, Papua New Guinea, will receive one dose of 13-valent pneumococcal conjugate vaccine (PCV). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 13-valent pneumococcal conjugate vaccine | Biological |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity | Mean Fold Increase (MFI; and 95% CI) in vaccine-serotype specific IgG concentrations at 28 days after compared to baseline (before vaccination) | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Reactogenicity | Proportion (% & 95% CI) of participants with local and systemic side effects 24-48 hours after vaccination | 24-48 hours after vaccination |
| Adverse events | Proportion (% & 95% CI) of participants reporting any unexpected adverse effect (AE) during 28 days after vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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50 healthy non-pregnant women aged between 18-45 years old living in Goroka, Papua New Guinea.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Papua New Guinea Institute of Medical Research | Goroka | Eastern Hghlands Province | 441 | Papua New Guinea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33292822 | Derived | Javati S, Masiria G, Elizah A, Matlam JP, Ford R, Richmond PC, Lehmann D, Pomat WS, van den Biggelaar AHJ. An observational study of the reactogenicity and immunogenicity of 13-valent pneumococcal conjugate vaccine in women of childbearing age in Papua New Guinea. Pneumonia (Nathan). 2020 Nov 25;12(1):13. doi: 10.1186/s41479-020-00076-1. |
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| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C538862 | 13-valent pneumococcal vaccine |
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| 28 days |
| D007239 | Infections |