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Study to Determine the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals; Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Study to Determine the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals; Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants

Immunogenicity and Safety Study of GSK Biologicals' Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants

NCT02096263•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' Infanrix hexa vaccine when administered to healthy infants as primary vaccination at 2, 4 and 6 months of age, co-administered with Prevnar and Rotarix with a booster dose of GSK Biologicals' Infanrix and Hiberix vaccines at 15-18 months of age.

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Subjects' parent(s)/ Legally Acceptable Representative(s) (LARs) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
•A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
•Born full-term (i.e. after a gestation period of 37 weeks to less than 42 completed weeks \[259 to 293 days\]).
•Written informed consent obtained from parent(s)/LAR(s) of the subject.
•Healthy subjects as established by medical history and clinical examination before entering into the study.
•Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrolment.

Exclusion Criteria

•Child in care
•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccines, 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. For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
•Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting from 30 days before the first vaccination until 30 days after Dose 3 (Epoch 001, primary vaccination) and from 30 days before the booster Dose 4 until 30 days after booster Dose 4 (Epoch 002, booster vaccination), i.e. the end of the study:
•* Inactivated influenza and hepatitis A vaccines are allowed throughout the study.
•* Routine administration(s) of vaccines are allowed from 30 days after the last dose of primary vaccination until 30 days before the booster dose and after post-booster blood sampling. Routine administration of measles-mumps-rubella vaccine, varicella, pneumococcal vaccines are allowed from 30 days after last dose of primary vaccine until 30 days before booster dose and from post-booster blood sampling, as well as according to the recommended immunization schedule in US.
•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 product (pharmaceutical product or device).
•History of Hib, diphtheria, tetanus, pertussis, pneumococcal, rotavirus, poliovirus and hepatitis B diseases.
•Previous vaccination against Hib, diphtheria, tetanus, pertussis, pneumococcus, rotavirus and/or poliovirus; more than one previous dose of hepatitis B vaccine.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
+11 more criteria

Locations (43)

GSK Investigational Site

Tucson, Arizona, United States

GSK Investigational Site

Fayetteville, Arkansas, United States

GSK Investigational Site

Anaheim, California, United States

GSK Investigational Site

Daly City, California, United States

GSK Investigational Site

Fresno, California, United States

GSK Investigational Site

Hayward, California, United States

GSK Investigational Site

Oakland, California, United States

GSK Investigational Site

Pleasanton, California, United States

GSK Investigational Site

Roseville, California, United States

GSK Investigational Site

Sacramento, California, United States

Key Dates

Start Date

April 16, 2014

Primary Completion Date

February 6, 2015

Completion Date

November 13, 2015

Last Updated

November 27, 2019

Enrollment

585

ACTUAL participants

Conditions

PoliomyelitisDiphtheriaHaemophilus Influenzae Type bTetanusAcellular PertussisHepatitis B

Interventions

Infanrix hexa

BIOLOGICAL

Pediarix

BIOLOGICAL

ActHIB

BIOLOGICAL

Pentacel

BIOLOGICAL

Engerix-B

BIOLOGICAL

Infanrix

BIOLOGICAL

Hiberix

BIOLOGICAL

Prevnar13

BIOLOGICAL

Rotarix

BIOLOGICAL

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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: November 27, 2019Data 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

Study to Determine the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals; Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants

Inclusion Criteria

Exclusion Criteria

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