NCT02447432

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 320 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 42 Days – 76 Days
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	Pneumococcal vaccine GSK1024850A (10Pn-PD-DiT) vaccine (4-dose presentation)	4 doses by intramuscular injection in the right left anterolateral thigh
BIOLOGICAL	Pneumococcal vaccine GSK1024850A (10Pn-PD-DiT) vaccine (1-dose presentation)	4 doses by intramuscular injection in the right anterolateral thigh
BIOLOGICAL	DTPw-HBV/Hib	3 doses by intramuscular injection in the left anterolateral thigh

Timeline

• Start date: 2015-06-11
• Primary completion: 2016-01-23
• Completion: 2016-05-22
• First posted: 2015-05-18
• Last updated: 2018-08-02
• Results posted: 2017-03-16

Locations

1 site across 1 country: Bangladesh