Last updated: 11/07/2018 05:46:42

Immunization of children previously primed with GSK pneumococcal vaccine GSK1024850A and of unprimed children in Nigeria

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GSK study ID
113199
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Clinicaltrials.gov ID
NCT01153893
See results summary
EudraCT ID
2012-000826-23
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Safety, reactogenicity and immunogenicity study of GSK Biologicals’ pneumococcal vaccine GSK1024850A, given either as a booster dose or as a 2-dose catch-up immunization in healthy Nigerian children
Trial description: 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 Nigerian 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).
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Number of subjects reporting Grade 3 symptoms (solicited and unsolicited).

Timeframe: Within 31 days (Day 0 to Day 30) after administration of a booster dose of Synflorix vaccine in the Synflorix/Infanrix primed Group.

Secondary outcomes:

Concentrations of antibodies against vaccine pneumococcal serotypes.

Timeframe: Prior to and one month after the booster immunisation for the Synflorix/Infanrix primed Group and prior to the first dose and one month after Dose 2 in the Synflorix/Infanrix unprimed Group

Concentrations of antibodies against cross-reactive pneumococcal serotypes.

Timeframe: Prior to and one month after the booster immunisation for the Synflorix/Infanrix primed Group and prior to the first dose and one month after Dose 2 in the Synflorix/Infanrix unprimed Group

Opsonophagocytic activity against vaccine pneumococcal serotypes.

Timeframe: One month after the booster immunisation for the Synflorix/Infanrix primed Group and one month after Dose 2 in the Synflorix/Infanrix unprimed Group

Opsonophagocytic activity against cross-reactive pneumococcal serotypes.

Timeframe: One month after the booster immunisation for the Synflorix/Infanrix primed Group and one month after Dose 2 in the Synflorix/Infanrix unprimed Group

Concentration of antibodies against protein D (PD).

Timeframe: Prior to and one month after the booster immunisation for the Synflorix/Infanrix primed Group and prior to the first dose and one month after Dose 2 in the Synflorix/Infanrix unprimed Group

Number of subjects reporting any and grade 3 solicited local AEs.

Timeframe: Within 4 days (Days 0-3) after vaccination.

Number of subjects reporting any, grade 3 and related solicited general AEs.

Timeframe: Within 4 days (Days 0-3) after vaccination.

Number of subjects reporting unsolicited AEs.

Timeframe: Within 31 days (Days 0-30) after vaccination

Number of subjects reporting serious adverse events (SAEs).

Timeframe: During the entire study period, from the vaccination visit at Day 0 up to the end of the follow-up visit at Month 1 for the Synflorix/Infanrix primed Group and up to Month 3 for the Synflorix/Infanrix unprimed Group.

Interventions:
Biological/vaccine: Pneumococcal vaccine GSK1024850A
Biological/vaccine: InfanrixTM
Enrollment:
105
Observational study model:
Not applicable
Primary completion date:
2011-16-02
Time perspective:
Not applicable
Clinical publications:
Odusanya OO et al. (2013) Safety and immunogenicity of 10-valent pneumococcal nontypeable Hemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Nigerian children: Booster dose and 2-dose catch-up regimens in the second year of life. Hum Vaccin Immunother. 10(3):757-766.
Medical condition
Infections, Streptococcal
Product
GSK1024850A
Collaborators
Not applicable
Study date(s)
October 2010 to February 2011
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
15 - 21 months
Accepts healthy volunteers
Yes
  • 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.
  • Use of any investigational or non-registered product 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.
Inclusion and exclusion 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 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.
    • 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.

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Ikeja / Lagos, Nigeria, P.M.B. 21266
Status
Study Complete
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Study documents

Clinical study report
Available language(s): English
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Scientific result summary
Available language(s): English
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If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2011-16-02
Actual study completion date
2011-16-02

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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