Clinical trial NCT01641133: Primary Vaccination With Either Synflorix™ or Prevenar 13™ or Both Vaccines and Booster Vaccination With Synflorix™
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™
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Streptococcal
Streptococcus Pneumoniae Vaccines
Keywords: pneumococcal conjugate vaccine
Synflorix
Prevnar 13
Pneumococcal diseases
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-07-16
Enrollment: 457
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: This study is partially blinded as the primary phase will be conducted in an observer-blind method and booster phase will be open method.

Eligibility 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.

Primary outcomes:
measure: 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:
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: Number of Subjects With Unsolicited AEs - Primary Period
timeFrame: During the 31-day (Days 0-30) post-primary vaccination period
measure: Number of Subjects With Unsolicited AEs - Booster Period
timeFrame: During the 31-day (Days 0-30) post-booster vaccination period
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: From first vaccination (Month 0) up to study end (11-14 months)
measure: 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)
measure: 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)
measure: 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)
Other outcomes:
Locations:
city: Cuernavaca
country: Mexico
facility: GSK Investigational Site
state: Morelos
city: Monterrey
country: Mexico
facility: GSK Investigational Site
state: Nuevo León
city: Mexico
country: Mexico
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: de Los Santos AM, Rodriguez-Weber MA, Sanchez-Marquez P, Traskine M, Carreno-Manjarrez R, Cervantes-Apolinar MY, Strezova A, Ruiz-Guinazu J, Ortega-Barria E, Borys D. Can two different pneumococcal conjugate vaccines be used to complete the infant vaccination series? A randomized trial exploring interchangeability of the 13-valent pneumococcal conjugate vaccine and the pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine. Expert Rev Vaccines. 2020 Nov;19(11):995-1010. doi: 10.1080/14760584.2020.1843431.