Last updated: 07/17/2024 15:10:50
Safety and immunogenicity study of a booster dose of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine.
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: To assess the safety, reactogenicity & immunogenicity of a 4th dose of GSK Biologicals’ pneumococcal vaccine or Prevenar™ in children (12-18 months) previously vaccinated in the primary study NCT00307554 with either pneumococcal vaccine or Prevenar™
Trial description: This study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of GSK Biologicals’ pneumococcal conjugate vaccine compared to Prevenar™ given at 12-18 mo of age to children primed with either pneumococcal vaccine or Prevenar™ in study 105553. Antibody persistence will be evaluated at 8-14 mo after completion of the 3-dose immunization course in study 105553 (NCT00307554). The immune response to a booster dose of GSK Biologicals’ pneumococcal conjugate vaccine will also be evaluated when given at 12-18 mo to subjects not primed with GSK Biologicals’ vaccine but with Prevenar™.The study has 3 groups. 1 group of children primed with GSK Biologicals’ pneumococcal conjugate vaccine will receive a booster dose of the same vaccine. 2nd group of children primed with Prevenar™ will receive a booster dose of Prevenar™ (control group). 3rd group of children primed with Prevenar™ will receive a booster dose of GSK Biologicals’ pneumococcal conjugate vaccine. All children will receive concomitantly a booster dose of DTPa-HBV-IPV/Hib vaccine.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Number of subjects with rectal temperature above (>) 39.0 degrees Celsius (°C) post booster between the Synflorix-Synflorix and Prevenar-Prevenar groups
Timeframe: Within 4 days (Days 0-3) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007
Secondary outcomes:
Number of subjects with any and Grade 3 solicited local symptoms
Timeframe: Within 4 days (Days 0-3) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007
Number of subjects with any and any Grade 3 solicited general symptoms
Timeframe: Within 4 days (Days 0-3) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007
Number of subjects with unsolicited adverse events (AEs)
Timeframe: Within 31 days (Day 0-30) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007
Number of subjects with serious adverse events (SAEs) during the Active Phase of the study
Timeframe: Throughout the Active Phase of the study, that is, within 31 days (Day 0-30) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007
Number of subjects with serious adverse events (SAEs) during the entire study
Timeframe: Throughout the study period, from Month 0 prior to booster vaccination up to Month 6, end of the ESFU in this study 10PN-PD-DIT-007
Number of subjects seroprotected as regards anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antigens – by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA)
Timeframe: Prior to (PRE) and one month after (Month 1) booster vaccination
Antibody concentrations against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) – by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA)
Timeframe: Prior to (PRE) and one month (Month 1) post booster vaccination
Opsonophagocytic activity (OPA) titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
Timeframe: Prior to (PRE) and one month (Month 1) post booster vaccination
Antibody concentrations to protein D (Anti-PD) - by Enzyme-Linked Immunosorbent Assay (ELISA)
Timeframe: Prior to (PRE) and one month (Month 1) post booster vaccination
Anti-polyribosyl ribitol phosphate (anti-PRP) antibody concentrations
Timeframe: Prior to (PRE) and one month (Month 1) post booster vaccination
Anti-pertussis toxoid (Anti-PT), anti- filamentous haemagglutinin (Anti-FHA) and anti-pertactin (Anti-PRN) antibody concentrations
Timeframe: Prior to (PRE) and one month (Month 1) post booster vaccination
Anti-diphtheria (Anti-D) and anti-tetanus toxoids (Anti-TT) antibody concentrations
Timeframe: Prior to (PRE) and one month (Month 1) post booster vaccination
Anti-hepatitis B surface antigen (HBs) antibody concentrations
Timeframe: Prior to (PRE) and one month (Month 1) post booster vaccination
Anti-polio type 1, 2 and 3 (Anti-Polio 1, 2 and 3) antibody titers
Timeframe: Prior to (PRE) and one month (Month 1) post booster vaccination
Number of subjects booster (BST) responder to pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin antigens
Timeframe: One month (Month 1) post booster vaccination
Interventions:
Biological/vaccine: Synflorix
Biological/vaccine: Prevenar
Biological/vaccine: Infanrix hexa
Enrollment:
1200
Observational study model:
Not applicable
Primary completion date:
2007-04-06
Time perspective:
Not applicable
Clinical publications:
Wysocki J et al. (2009) Immunogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when coadministered with different Neisseria meningitidis serogroup C conjugate vaccines. Pediatr Infect Dis J. 28(4):S77-88.
Chevallier B et al. (2009) Safety and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when coadministered with routine childhood vaccines. Pediatr Infect Dis J. 28(4):109-118.
Knuf M et al. (2009) Immunogenicity of routinely used childhood vaccines when coadministered with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Pediatr Infect Dis J. 28(4):97-108.
Silfverdal SA et al. (2016) Safety profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Expert Rev Vaccines. [Epub ahead of print]
Vesikari T et al. (2009) Immunogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) compared to the licensed 7vCRM vaccine. Pediatr Infect Dis J. 28(4):66-76.
Medical condition
Infections, Streptococcal
Product
GSK1024850A
Collaborators
Not applicable
Study date(s)
September 2006 to November 2007
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
12 - 18 months
Accepts healthy volunteers
Yes
- a healthy male or female, 12 to 18 months of age at the time of vaccination, who received at least one dose of either pneumococcal conjugate vaccine or Prevenar™ during study 105553 and with written informed consent obtained from the parent/guardian of the subject.
- use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the vaccination, or planned use during the entire study period (active phase and safety follow-up).
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before vaccination up to Visit 2.
Inclusion and exclusion criteria
Inclusion criteria:
- a healthy male or female, 12 to 18 months of age at the time of vaccination, who received at least one dose of either pneumococcal conjugate vaccine or Prevenar™ during study 105553 and with written informed consent obtained from the parent/guardian of the subject.
Exclusion criteria:
- use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the vaccination, or planned use during the entire study period (active phase and safety follow-up).
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before vaccination up to Visit 2.
- Administration of any additional pneumococcal vaccine or DTPa-combined vaccine since end of study 105553. Children with a history of seizures or neurological disease, allergic disease, immunosuppressive or immunodeficient condition.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
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
2007-04-06
Actual study completion date
2007-06-11
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.
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