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

NCT ID: NCT02447432

Last Updated: 2018-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-11
• Study Completion Date: 2016-05-22

Brief Summary

The primary aim of the study is to demonstrate that an investigational 4-dose presentation of the 10Pn-PD-DiT vaccine with preservative is non-inferior to the licensed presentation of Synflorix (preservative-free) in terms of immune responses to the 10 vaccine pneumococcal serotypes (primary objective) and to the vaccine-related pneumococcal serotype 19A (first secondary objective), after administration of a 3-dose primary vaccination course at 6, 10 and 18 weeks of age co-administered with the first 2 doses of DTPw-HBV/Hib vaccine given at 6, 10 and 14 weeks of age (according to the Expanded Program on Immunization (EPI) schedule).

In addition, the study will also assess the safety, reactogenicity, immunogenicity and antibody persistence (approximately 7 months following primary vaccination) of the 4-dose presentation of the 10Pn-PD-DiT vaccine given as primary vaccination schedule at 6, 10 and 18 weeks of age followed by a booster dose at 38 weeks.

This study also aims at assessing the safety, reactogenicity and immunogenicity of the 4-dose presentation of the 10Pn-PD-DiT vaccine when given as a booster dose at approximately 9 months of age.

Conditions

Infections, Streptococcal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

10Pn_4d Group

Subjects received 10Pn-PD-DIT, in its investigational 4-dose presentation (4 doses in total with each single dose injected at Study Months 0, 1, 3 and 8), co administered with DTPw-HBV/Hib vaccine (3 doses injected at Study Months 0, 1 and 2).

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

4 doses by intramuscular injection in the right left anterolateral thigh

DTPw-HBV/Hib

Intervention Type: BIOLOGICAL

3 doses by intramuscular injection in the left anterolateral thigh

10Pn Group

Subjects received 10Pn-PD-DIT, in its licensed 1-dose presentation (4 doses in total with each single dose injected at Study Months 0, 1, 3 and 8), co administered with DTPw-HBV/Hib vaccine (3 doses injected at Study Months 0, 1 and 2).

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: BIOLOGICAL

4 doses by intramuscular injection in the right anterolateral thigh

DTPw-HBV/Hib

Intervention Type: BIOLOGICAL

3 doses by intramuscular injection in the left anterolateral thigh

Interventions

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

4 doses by intramuscular injection in the right left anterolateral thigh

Intervention Type: BIOLOGICAL

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

4 doses by intramuscular injection in the right anterolateral thigh

Intervention Type: BIOLOGICAL

DTPw-HBV/Hib

3 doses by intramuscular injection in the left anterolateral thigh

Intervention Type: BIOLOGICAL

Other Intervention Names

10Pn; 10PN-PD-DiT; GSK Biologicals' 10-valent pneumococcal polysaccharide and non-typeable Haemophilus influenzae protein D conjugate GSK1024850A (10Pn-PD-DiT); Synflorix™; GSK Biologicals' 10-valent pneumococcal polysaccharide and non-typeable Haemophilus influenzae protein D conjugate GSK1024850A (10Pn-PD-DiT) vaccine; GSK Biologicals' diphtheria-tetanus-whole cell pertussis-hepatitis B and Haemophilus influenzae type b vaccine

Eligibility 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.

• Minimum Eligible Age: 42 Days
• Maximum Eligible Age: 76 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Dhaka, , Bangladesh

Countries

Bangladesh

References

Zaman K, Zaman SF, Zaman F, Aziz A, Faisal SB, Traskine M, Habib MA, Ruiz-Guinazu J, Borys D. Immunologic non-inferiority and safety of the investigational pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) 4-dose vial presentation compared to the licensed PHiD-CV 1-dose vial presentation in infants: A phase III randomized study. Vaccine. 2018 Jan 29;36(5):698-706. doi: 10.1016/j.vaccine.2017.12.034. Epub 2017 Dec 23.

Reference Type: DERIVED

PMID: 29277353 (View on PubMed)

Related Links

https://clinicalstudydatarequest.com

IPD for this study will be made available via the Clinical Study Data Request site.

Other Identifiers

200799

Identifier Type: -

Identifier Source: org_study_id