Phase 3
Completed N=282
Booster and Catch-up Vaccination With Vaccine GSK1024850A
Infections, Streptococcal
Source: ClinicalTrials.gov NCT01030822 ↗
Enrolled (actual)
282
Serious AEs
1.1%
Results posted
Feb 2017
Primary outcomePrimary: Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes — 0.37; 0.31; 4.78; 5.98 µg/mL
◆ Published Evidence
Emerging
9citations · ~1 / year
Randomized, open-label study of the impact of age on booster responses to the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine in children in India.
Summary
The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of pneumococcal vaccine GSK1024850A administered either at 9-18 months or 15-18 months of age in children primed in primary study NCT00814710.
This study also aims to assess the persistence of antibodies induced following primary vaccination with pneumococcal vaccine GSK1024850A in primary study NCT00814710 prior to booster vaccination and following vaccination in the present study at approximately 24 months of age.
The study is also designed to evaluate the immunogenicity, safety and reactogenicity of pneumococcal vaccine GSK1024850A when administered as a catch-up vaccination (2+1) in the second year of life in children unprimed with vaccine GSK1024850A in study NCT00814710.
Linked Publications
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Randomized, open-label study of the impact of age on booster responses to the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine in children in India.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes |
0.04; 2.5; 1.03; 3.32; 0.04; 5.89 | — |
| SECONDARY Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes |
0.04; 2.5; 1.03; 3.32; 0.04; 5.89 | — |
| SECONDARY Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Persistence) |
0.37; 0.3; 0.04; 0.76; 0.57; 0.04 | — |
| SECONDARY Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Persistence) |
16.5; 15.6; 4.4; 70.3; 102.8; 6.2 | — |
| SECONDARY Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F |
4.3; 76.1; 18.1; 309.8; 5.8; 2256.3 | — |
| SECONDARY Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Persistence) |
0.19; 0.22; 0.03; 0.31; 0.33; 0.06 | — |
| SECONDARY Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A |
0.03; 0.35; 0.33; 0.76; 0.06; 2.49 | — |
| SECONDARY Opsonophagocytic Activity (OPA) Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Persistence) |
21.1; 30.1; 10.3; 9.7; 7.4; 4.8 | — |
| SECONDARY Opsonophagocytic Activity (OPA) Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A |
10.2; 324.9; 329; 616.2; 4.8; 506.6 | — |
| SECONDARY Concentrations of Antibodies Against Protein D (Anti-PD) (Persistence) |
776.3; 618.6; 71.6 | — |
| SECONDARY Concentrations of Antibodies Against Protein D (Anti-PD) |
72.5; 527.7; 443.2; 1727.2 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms |
31; 25; 26; 2; 4; 5 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms |
5; 4; 5; 0; 0; 2 | — |
| SECONDARY Number of Subjects With Unsolicited Adverse Events (AEs) |
7; 1; 5 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
2; 0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female subjects for whom the investigator believes that their parent(s)/ guardian(s) can and will comply with the requirements of the protocol.
- Written, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
For primed subjects:
- Completion of the full vaccination course in study NCT00814710.
- 9-18 months of age at the time of randomization.
- Group A: 9-18 months of age at the time of booster vaccination.
- Group B: 15-18 months of age at the time of booster vaccination.
For unprimed subjects (Group C):
- Enrolled in study NCT00814710.
- 12-18 months of age at the time of first vaccination.
Exclusion Criteria
- Use of any investigational or non-registered product within 30 days preceding the vaccination, or planned use during the study period.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
- Administration of immunoglobulins and/or any blood products within three months preceding the vaccination or planned administration during the study period.
- Administration of any pneumococcal vaccine since the end of study NCT00814710.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of reactions or allergic disease likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at the time of enrolment.
Data sourced from ClinicalTrials.gov (NCT01030822) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.