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Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib, Compared to DTPa-HBV-IPV and Hib Administered Separately | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib, Compared to DTPa-HBV-IPV and Hib Administered Separately

Study to Assess the Immunogenicity and Reactogenicity of DTPa-HBV-IPV Vaccine Mixed With Hib Vaccine to Healthy Infants at 3, 5 and 11 Months of Age, Compared to Each Vaccine Administered Separately

NCT01457508•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

This study will assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals' (formerly SB Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared with separate administration of DTPa-HBV-IPV (Infanrix penta™) and Hib (Hiberix™) vaccine administered at 3, 5 and 11 (or 12) months of age.

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•A male or female 3 months of age at the time of the first vaccination.
•Free of obvious health problems as established by medical history and clinical examination before entering into the study.
•Written informed consent obtained from the parents or guardians of the subject after they have been advised of the risks and benefits of the study in a language which they clearly understood, and before performance of any study procedure.

Exclusion Criteria

•The following criteria should be checked at the time of study entry. If any apply at the time of study entry, the subject must not be included in the study:
•Use of any investigational or non-registered 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.
•Administration of chronic immunosuppressants or other immune-modifying drugs within three months before vaccination.
•Administration of a vaccine not foreseen by the study within 30 days before each dose of the study vaccines and ending 30 days after.
•Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease.
•History of /or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease or infection.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including allergic reactions to neomycin and polymyxin B.
•Major congenital defects or serious chronic illness.
•History of seizures or of any neurological disease at study entry.
+2 more criteria

Key Dates

Start Date

January 1, 1999

Primary Completion Date

March 1, 2000

Completion Date

March 1, 2000

Last Updated

June 16, 2017

Enrollment

440

ACTUAL participants

Conditions

Hepatitis BDiphtheriaHaemophilus Influenzae Type b (Hib)PoliomyelitisPertussisTetanus

Interventions

DTPa-HBV-IPV/Hib (Infanrix hexa™)

BIOLOGICAL

DTPa-HBV-IPV (Infanrix penta™)

BIOLOGICAL

Hib (Hiberix™)

BIOLOGICAL

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 in Participants With Chronic Hepatitis B Virus Infection

NCT07024641

Hepatitis B Virus Infection

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RECRUITINGPHASE1

Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B

NCT06671093

Chronic Hep BChronic Hepatitis b+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 16, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib, Compared to DTPa-HBV-IPV and Hib Administered Separately

Inclusion Criteria

Exclusion Criteria

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 in Participants With Chronic Hepatitis B Virus Infection

Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B

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Analysis of Methylomic Features and Prognostic Risk Prediction in Patients With Hepatitis B-related Acute-on-chronic Liver Failure

hUC Mesenchymal Stem Cells (19#iSCLife®-LC) in the Treatment of Decompensated Hepatitis b Cirrhosishepatitis b Cirrhosis

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