A Study to Compare the Immunogenicity of GSK Biologicals' 10Pn-PD-DiT 4-dose Presentation to the Licensed 1-dose Synflorix™ (10Pn-PD-DiT) Vaccine When Co-administered With DTPw-combination Vaccine in Healthy Infants

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02447432
• Date of registration: 07/05/2015
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: A Study to Compare the Immunogenicity of GSK Biologicals' 10Pn-PD-DiT 4-dose Presentation to the Licensed 1-dose Synflorix™ (10Pn-PD-DiT) Vaccine When Co-administered With DTPw-combination Vaccine in Healthy Infants
• Scientific title: Study to Compare Immunogenicity of GSK Biologicals' 10Pn-PD-DiT 4-dose Presentation to the Licensed Synflorix™ (10Pn-PD-DiT) Vaccine When Co-administered With DTPw-combination Vaccine in Healthy Infants
• Date of first enrolment: June 11, 2015
• Target sample size: 320
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02447432
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Bangladesh

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects for whom, in the opinion of the investigator, the parent(s)/Legally
Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the
protocol (e.g., return for vaccination and follow-up visits).

- A male or female between, and including 6-10 weeks (42-76 days) of age at the time of
the first vaccination.

- Written or oral, signed or thumb-printed informed consent obtained from the
parent(s)/LAR(s) of the subject. For all subjects, the consent form should be
countersigned by a witness.

- Healthy subjects as established by medical history and clinical examination before
entering into the study.

- Born full-term (i.e., after a gestation period from 37 to 42 weeks).

Exclusion Criteria:

- Child in care.

- Use of any investigational or non-registered product (drug or vaccine) 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 (defined as more than 14 days in total) of immunosuppressants
or other immune-modifying drugs since birth. Inhaled and topical steroids are allowed.

- Planned administration of long-acting immune-modifying drugs at any time during the
study period (e.g., infliximab).

- Administration or planned administration of a vaccine not foreseen by the study
protocol administered during the period starting from 30 days before each dose of
study vaccines and ending 30 days after with the following exceptions:

- 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 vaccine/product

- Previous vaccination against diphtheria, tetanus, pertussis, H. influenzae type b
and/or S. pneumoniae.

- History of, or intercurrent diphtheria, tetanus, pertussis, hepatitis B, and H.
influenzae type b disease.

- History of any reaction or hypersensitivity likely to be exacerbated by any component
of the vaccines.

- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
medical history and physical examination (no laboratory testing required).

- Family history of congenital or hereditary immunodeficiency.

- Major congenital defects or serious chronic illness.

- History of any neurological disorders or seizures.

- Acute disease and/or fever at the time of enrolment.

- Fever is defined as temperature = 37.5°C for oral, axillary or tympanic route, or =
38.0°C on rectal route. The preferred route for recording temperature in this study
will be axillary.

- Subjects with a minor illness without fever may, be enrolled at the discretion of the
investigator.

- Administration of immunoglobulins and/or any blood products since birth or planned
administration during the study period (Hepatitis B immunoglobulins at birth are
allowed).

- Any medical condition which might interfere with the assessment of the study
objectives in the opinion of the investigator.



Age minimum: 42 Days
Age maximum: 76 Days
Gender: All

Health Condition(s) or Problem(s) studied

Infections, Streptococcal

Intervention(s)

Biological: Pneumococcal vaccine GSK1024850A (10Pn-PD-DiT) vaccine (1-dose presentation)

Biological: DTPw-HBV/Hib

Biological: Pneumococcal vaccine GSK1024850A (10Pn-PD-DiT) vaccine (4-dose presentation)

Primary Outcome(s)

Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001) [Time Frame: At study Month 4, e. g. at one month post-Dose 3 of pneumococcal vaccine]

Secondary Outcome(s)

Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) [Time Frame: At Month 8 and Month 9, e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine]

Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) [Time Frame: Within the 4-day (Days 0-3) post-vaccination period following each primary dose of 10Pn-PD-DiTvaccine]

Number of Subjects With Any Serious Adverse Events (SAEs) During the Entire Duration of the Study [Time Frame: From Day 0 to Month 9]

Number of Subjects With Any Serious Adverse Events (SAEs) (Epoch 001) [Time Frame: From Month 0 to Month 4]

Number of Subjects With Any Unsolicited Adverse Events (AEs) (Epoch 002) [Time Frame: Within the 31-day (Days 0-30) period post booster vaccination]

Concentrations of Antibodies Against Protein D (Anti-PD) (Epoch 001) [Time Frame: At study Month 4, e. g. at one month post-Dose 3 of pneumococcal vaccine]

Concentrations of Antibodies Against Protein D (Anti-PD) (Epoch 002) [Time Frame: At study Month 9, e.g.: at one month post booster vaccination with pneumococcal vaccine]

Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) [Time Frame: At study Month 8 and Month 9, e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine]

Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002) [Time Frame: Within the 4-day (Days 0-3) period after booster vaccination]

Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) [Time Frame: Within the 4-day (Days 0-3) post-vaccination period following each primary dose of 10Pn-PD-DiTvaccine]

Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 002) [Time Frame: Within the 4-day (Days 0-3) period after booster vaccination]

Number of Subjects With Any Unsolicited Adverse Events (AEs) (Epoch 001) [Time Frame: Within the 31-day (Days 0-30) period post primary vaccination, across doses]

Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001) [Time Frame: At study Month 4, e. g. at one month post-Dose 3 of pneumococcal vaccine]

Secondary ID(s)

200799

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 16/03/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02447432