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| ID | Type | Description | Link |
|---|---|---|---|
| 213503/048 | |||
| 217744/085 |
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This study aims to analyse the serologic response to PCV-1 in the PEDIARIX® [GSK Biologicals' Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine] and KINRIX® (GSK Biologicals' Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) vaccine products. The samples have been collected at pre-determined time points from a subset of subjects who participated in selected studies [217744/085 and 213503/048] conducted in the United States.
Serum samples from the previously conducted clinical trials (217744/085 and 213503/048) are used in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Subjects received 3 doses of the combination DTaP-HepB-IPV vaccine or separately administered DTaP, HepB, and IPV vaccines at 2, 4, and 6 months of age, in a previous study (217744/085). |
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| Group B | Subjects received a single dose of the combination DTaP-IPV vaccine or separately administered DTaP and IPV vaccines at 4-6 years of age, in a previous study (213503/048). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serum sample | Procedure | Serum samples collected at pre-determined time points in previously completed studies (217744/085 and 213503/048) will be analysed to detect the presence of anti PCV-1 antibodies. |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of serum anti-PCV-1 antibody. | At Day 0 and post vaccination time points (up to 1 month after vaccination). |
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Inclusion Criteria:
Exclusion Criteria:
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Infants aged 2 and 6 months who were previously given a primary vaccination series consisting of a single dose of combination DTaP-HepB-IPV (PEDIARIX®) vaccine at 2, 4, and 6 months of age or separately administered DTaP (INFANRIX®), HepB (ENGERIX-B®), and IPV (Sanofi-Pasteur's IPOL) vaccines in the study 217744/085 and toddlers aged 4-6 years who were previously vaccinated with a single dose of either the combination DTaP-IPV (KINRIX®) vaccine or separately administered DTaP and IPV vaccines in the study 213503/048.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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Serum