CompletedPhase 2

Impact of GSK Biologicals' 2189242A Vaccine on Nasopharyngeal Carriage, Safety & Immunogenicity in Children & Infants

The Gambia1,320 participantsStarted 2011-02-09

Plain-language summary

This study will assess the impact on nasopharyngeal carriage, safety and immunogenicity of GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose vaccination course and co-administered with other routine paediatric vaccines in infants in The Gambia. Two formulations containing different doses of pneumococcal antigen and two different schedules will be tested in infants.

Who can participate

Age range

56 Days – 4 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Inclusion criteria for subjects in Cohort 1 (children) and Cohort 2 (infants): * Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol * Male or female between, and including, * 2 to 4 years of age at the time of the first vaccination for subjects in Cohort 1 (children). * 8 to 10 weeks (56-76 days) of age at the time of the first vaccination for subjects in Cohort 2 (infants). * Signed or thumb-printed informed consent obtained from the parents/LAR(s) of the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study. * Permanent residence in the study area and no intention of leaving during the study period. Additional inclusion criteria for subjects in Cohort 1: • Previously completed three-dose primary course of diphtheria-tetanus-pertussis (DTP) vaccination. Exclusion Criteria: Exclusion criteria for subjects in Cohort 1 (children) and Cohort 2 (infants): * Child in care. * Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * Planned administration/administration of a vaccine not foreseen by the study protocol during the…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Subjects With Any and Grade 3 Solicited Local Symptoms and Grade 3 Solicited Local Symptoms With Relationship to Vaccination - For Step 1/Cohort 1 Subjects

Timeframe: Within the 4-day (Days 0-3) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)

Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects

Timeframe: Within the 4-day (Days 0-3) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)

Number of Subjects With Any and Grade 3 Unsolicited Adverse Events (AEs) With and Without Relationship to Vaccination - In Step 1/Cohort 1 Subjects

Timeframe: Within the 31-day (Days 0-30) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)

Number of Subjects With Any Serious Adverse Events (SAEs) and With SAE(s) With Relationship to Vaccination - In Step 1/Cohort 1 Subjects

Timeframe: From Day 0 to Month 1

Number of Subjects With Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx - For Cohort 2/Step 2, Subjects Receiving the 3+0 Schedule

Timeframe: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™)

Trial details

NCT IDNCT01262872

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-03-18

Results submitted2014-03-13

View on ClinicalTrials.gov More Infections, Streptococcal trials

Plain-language summary

Who can participate

Age range

56 Days – 4 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Subjects With Any and Grade 3 Solicited Local Symptoms and Grade 3 Solicited Local Symptoms With Relationship to Vaccination - For Step 1/Cohort 1 Subjects

Timeframe: Within the 4-day (Days 0-3) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)

Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination - For Step 1/Cohort 1 Subjects

Timeframe: Within the 4-day (Days 0-3) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)

Number of Subjects With Any and Grade 3 Unsolicited Adverse Events (AEs) With and Without Relationship to Vaccination - In Step 1/Cohort 1 Subjects

Timeframe: Within the 31-day (Days 0-30) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)

Number of Subjects With Any Serious Adverse Events (SAEs) and With SAE(s) With Relationship to Vaccination - In Step 1/Cohort 1 Subjects

Timeframe: From Day 0 to Month 1

Number of Subjects With Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx - For Cohort 2/Step 2, Subjects Receiving the 3+0 Schedule

Timeframe: At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™)