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Primary vaccination with either Synflorix™ or Prevenar 13™ or both vaccines and booster vaccination with Synflorix™

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GSK study ID
115992
See study documents
Clinicaltrials.gov ID
NCT01641133
See results summary
EudraCT ID
2013-003479-36
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: Two-dose primary vaccination with either GSK Biologicals' 10-valent pneumococcal vaccine (Synflorix™) or Pfizer’s Prevenar 13™ or both vaccines followed by a booster dose of Synflorix™
Trial description: The primary aim of this study is to assess the reactogenicity of Synflorix vaccine and Prevenar 13 vaccine after primary vaccination at 2 and 4 months of age with either Synflorix or Prevenar 13 vaccine or Prevenar 13 and Synflorix, respectively. In addition, this study aims at assessing the safety, reactogenicity, immunogenicity and antibody persistence (approximately 8-11 months following primary vaccination) of the Synflorix vaccine and Prevenar 13 vaccine after primary vaccination at 2 and 4 months of age with either Synflorix or Prevenar 13 vaccine or Prevenar 13 and Synflorix, respectively. This study also aims at assessing the safety, reactogenicity and immunogenicity of the Synflorix vaccine when given as a booster dose at 12-15 months of age following primary vaccination at 2 and 4 months of age with either Synflorix vaccine or Prevenar 13 vaccine or Prevenar 13 and Synflorix respectively.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Number of subjects with grade 3 Adverse Events (AEs) (solicited and unsolicited) - primary period

Timeframe: Within 31-day (Day 0-Day 30) after any dose of primary vaccination

Secondary outcomes:

Number of subjects reporting any and grade 3 solicited local symptoms - primary period

Timeframe: During the 4-day (Days 0-3) post-vaccination period following each primary dose

Number of subjects reporting any and grade 3 solicited local symptoms - booster period

Timeframe: During the 4-day (Days 0-3) post-booster vaccination period

Number of subjects reporting any, grade 3 and related solicited general symptoms - primary period

Timeframe: During the 4-day (Days 0-3) post-vaccination period following each primary dose

Number of subjects reporting any, grade 3 and related solicited general symptoms - booster period

Timeframe: During the 4-day (Days 0-3) post-booster vaccination period

Number of subjects reporting any and grade 3 symptoms (solicited and unsolicited) - booster period

Timeframe: During the 31-day (Days 0-30) post-booster vaccination period

Number of subjects with unsolicited AEs - primary period

Timeframe: During the 31-day (Days 0-30) post-primary vaccination period

Number of subjects with unsolicited AEs - booster period

Timeframe: During the 31-day (Days 0-30) post-booster vaccination period

Number of subjects with Serious Adverse Events (SAEs)

Timeframe: From first vaccination (Month 0) up to study end (11-14 months)

Antibody concentrations against pneumococcal serotypes

Timeframe: At study Month 3 (one month after the primary vaccination), at study Month 10 (prior to booster vaccination) and at study Month 11 (one month after the booster vaccination)

Concentrations of antibodies against protein D (Anti-PD)

Timeframe: At study Month 3 (one month after primary vaccination) and at study Month 11 (one month after booster vaccination)

Titers for opsonophagocytic activity against pneumococcal serotypes

Timeframe: At study Month 3 (one month after the primary vaccination), at study Month 10 (prior to booster vaccination) and at study Month 11 (one month after the booster vaccination)

Interventions:
Biological/vaccine: Synflorix (3-Dose)
Biological/vaccine: Synflorix (2-Dose)
Biological/vaccine: Synflorix (Single Dose)
Biological/vaccine: Prevenar 13 (Single Dose)
Biological/vaccine: Prevenar 13 (2-Dose)
Enrollment:
457
Observational study model:
Not applicable
Primary completion date:
2013-15-07
Time perspective:
Not applicable
Clinical publications:
A. Mascareñas de Los Santos, M. A. Rodríguez-Weber, P. Sánchez-Márquez, M. Traskine, R. Carreño-Manjarrez, M. Y. Cervantes-Apolinar, A. Strezova, J. Ruiz-Guiñazú, E. Ortega-Barria, D. Borys. CLI_10PN-PD-DIT-082_Can two different pneumococcal conjugate vaccines be used to complete the infant vaccination series? A randomised trial exploring interchangeability of the 13-valent pneumococcal conjugate vaccine and the pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine_Vaccine. Expert Rev Vaccines. 2020 Nov;19(11):995-1010. doi: 10.1080/14760584.2020.1843431.
Medical condition
Infections, Streptococcal
Product
GSK1024850A
Collaborators
Not applicable
Study date(s)
September 2012 to May 2014
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
6 - 12 weeks
Accepts healthy volunteers
Yes
  • Subjects who the investigator believes that 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, 6-12 weeks of age at the time of the first vaccination.
  • Child in care.
  • Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccines, or planned use during the entire study period.
Inclusion and exclusion criteria
Inclusion criteria:

    Subjects who the investigator believes that 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, 6-12 weeks of age at the time of the first vaccination.
    • Healthy subjects as established by medical history and clinical examination before entering into the study.
    • Born after a gestation period of at least 36 weeks.
    • Written informed consent obtained from the parent(s)/LAR(s) of the subject.
Exclusion criteria:

    Child in care.

    • Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccines, or planned use during the entire study period.
    • Chronic administration of immunosuppressants or other immune-modifying drugs since birth or planned use during the study.
    • 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.
    • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
    • History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine.
    • Major congenital defects or serious chronic illness.
    • History of any seizures or progressive neurological disease.
    • Administration of immunoglobulins and/or blood products since birth or planned use during the study.
    • Acute disease and/or fever at the time of enrolment.
    • Previous vaccination or planned vaccination during the study with any pneumococcal vaccine.

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Cuernavaca, Morelos, Mexico, 62210
Status
Study Complete
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Location
GSK Investigational Site
Mexico, Mexico, 04530
Status
Study Complete
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Location
GSK Investigational Site
Monterrey, Nuevo León, Mexico, 64460
Status
Study Complete
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Study documents

Clinical study report
Available language(s): English
Download document(s)

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
2013-15-07
Actual study completion date
2014-07-05

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

Additional information
Not applicable
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