A Randomized, Double blind, Active controlled, Phase 2 Clinical Trial to Assess the Immunogenicity and Safety of GBP411 in Healthy Infants

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20170109002

Enrollment

100

Registered

2017-01-09

Start date

2017-04-14

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumococcal Infections Pneumococcal Infections Immunologic Factors Streptococcal Infections Immunologic Factors Gram&#45

Interventions

The IP&#44

GBP411&#44

is a vial containing 1.0 mL. The study staff will need to pull exactly 0.5 mL out of 1.0 mL before the injection. The test vaccine will be administered as primary vaccination. A total of 3 doses of th

8 to 10 weeks after first dose&#44

and 39 to 52 weeks after birth. Each dose of GBP411 will be injected intramuscularly to the anterolateral region of the thigh.,The comparator vaccine&#44

Prevnar 13&#44

is a prefilled syringe containing 0.5 mL. The comparator vaccine will be administered as primary vaccination. A total of 3 doses of the comparator vaccine (Prevnar 13) will be administered at 6 to 10

and 39 to 52 weeks after birth. Each dose of Prevnar 13 will be injected intramuscularly to the anterolateral region of the thigh.

Experimental Biological/Vaccine,Active Comparator Biological/Vaccine

GBP411,Prevnar13

Eligibility

Sex/Gender

All

Age

6 Weeks to 10 Weeks

Inclusion criteria

Inclusion criteria: -Healthy Infants between 6 and 10 weeks of age (approximately 1.5 months) at the time of enrollment. -The LAR (Legally Authorized Representative) who understand the requirements of the study and voluntarily consent to participate in the study.

Exclusion criteria

Exclusion criteria: -Known hypersensitivity to any components of the pneumococcal vaccine -Any confirmed or suspected immunosuppressive or immunodeficient conditions -Coagulation disorder contraindicating IM(intramuscular) vaccination -Subject has received any licensed vaccine(not including BCG and Hepatitis B) -Participation to another study

Design outcomes

Primary

Measure	Time frame
Proportion of subjects with the targeted antibody concentration 1 month after the primary vaccination enzyme linked immunosorbent assay (ELISA)	—

Secondary

Measure	Time frame
Geometric mean concentration ratio 1 month after the booster vaccination enzyme linked immunosorbent assay (ELISA)	—

Countries

Thailand

Contacts

Public ContactJamaree Teeratakulpisarn@gmail.com

Faculty of Medicine, Khon Kaen University

teeratakulpisarn@gmail.com043348382

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026

A Randomized&#44; Double blind&#44; Active controlled&#44; Phase 2 Clinical Trial to Assess the Immunogenicity and Safety of GBP411 in Healthy Infants