Phase 3
Completed N=210
Immunization of Children Previously Primed With GSK Pneumococcal Vaccine GSK1024850A and of Unprimed Children in Mali
Infections, Streptococcal
Source: ClinicalTrials.gov NCT00985465 ↗
Enrolled (actual)
210
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcomePrimary: Number of Subjects With Grade 3 Adverse Events (Solicited and Unsolicited) — 3; 1; 2 Participants
◆ Published Evidence
Emerging
12citations · ~1 / year
Safety, reactogenicity and immunogenicity of a booster dose of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Malian children.
Summary
The purpose of this trial is to assess the safety, reactogenicity and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A when administered either as a booster dose or as a two dose catch-up vaccination in the second year of life to the Malian subjects previously enrolled in the primary vaccination study NCT00678301.
This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00678301).
Linked Publications (2)
-
Safety, reactogenicity and immunogenicity of a booster dose of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Malian children.
-
Safety, reactogenicity and immunogenicity of 2-dose catch-up vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Malian children in the second year of life: Results from an open study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Grade 3 Adverse Events (Solicited and Unsolicited) |
3; 1; 2 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms |
22; 0; 6; 0; 46; 1 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms |
1; 0; 1; 21; 0; 19 | — |
| SECONDARY Number of Subjects With Any Unsolicited Adverse Events (AEs) |
95; 57 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
0; 0 | — |
| SECONDARY Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F |
0.28; 0.04; 5.85; 3.2; 0.32; 0.06 | — |
| SECONDARY Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F |
9.3; 5.8; 661.7; 108.7; 24; 11.8 | — |
| SECONDARY Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A |
0.13; 0.04; 0.55; 0.1; 0.16; 0.06 | — |
| SECONDARY Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A |
18.7; 24; 100.7; 106.3; 6.2; 5.9 | — |
| SECONDARY Concentrations of Antibodies Against Protein D (PD) |
301.1; 62.1; 3710.1; 839.3 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR(s)) can and will comply with the requirements of the protocol.
- A male or female, between and including 15-21 months of age at the time of visit 1.
- For the Pn-Pn group, subjects who completed the full vaccination course in study NCT00678301. For the Zil-Pn group, subjects who were previously enrolled in the control group of study NCT00678301.
- Written informed consent, signed or thumb printed, obtained from the parent(s)/LAR(s) of the subject. Where parent(s)/LAR(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.
Exclusion Criteria
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s)/product(s) within 30 days preceding the first dose of vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
- Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after. Locally recommended vaccines for example Oral Polio Vaccine or influenza vaccine are always allowed, even if concomitantly administered with the study vaccines, but should be documented in the CRF.
- 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 (pharmaceutical product or device).
- Administration of any pneumococcal vaccine since the end of study NCT00678301.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, since the end of study NCT00678301, based on medical history and physical examination.
- Major congenital defects or serious chronic illness.
- History of any progressive neurological disorders or seizures.
- Acute disease and/or fever at the time of enrolment.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- Administration of immunoglobulins and/or any blood products less than 3 months prior to visit 1 or planned use during the study.
- Child in care.
Data sourced from ClinicalTrials.gov (NCT00985465) 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.