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Immunogenicity and Safety Study in Infants of GlaxoSmithKline Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib) Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01353703
Recruitment Status : Completed
First Posted : May 16, 2011
Results First Posted : January 25, 2019
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
This study evaluates the immunogenicity and safety of Infanrix hexa™ (DTPa-HBV-IPV/Hib) when administered as a primary vaccination course to Indian infants according to a 6-10-14 weeks or a 2-4-6 months schedule.

Condition or disease Intervention/treatment Phase
Poliomyelitis Tetanus Acellular Pertussis Haemophilus Influenzae Type b Diphtheria Hepatitis B Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b Vaccines Biological: Infanrix hexa™ Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Infanrix Hexa™ Vaccine in Healthy Infants in India
Actual Study Start Date : April 16, 2012
Actual Primary Completion Date : February 25, 2013
Actual Study Completion Date : February 25, 2013


Arm Intervention/treatment
Experimental: INFANRIX HEXA 6-10-14 GROUP
Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.
Biological: Infanrix hexa™
Intramuscular, three doses
Other Name: DTPa-HBV-IPV/Hib

Active Comparator: INFANRIX HEXA 2-4-6 GROUP
Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.
Biological: Infanrix hexa™
Intramuscular, three doses
Other Name: DTPa-HBV-IPV/Hib




Primary Outcome Measures :
  1. Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens [ Time Frame: One month post Dose 3 (Month 3 or Month 5) ]
    A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).

  2. Number of Seroprotected Subjects Against Hepatitis B (HBs) [ Time Frame: One month post Dose 3 (Month 3 or Month 5) ]
    A seroprotected subject was defined as a vaccinated subject with anti-HBS antibody concentration ≥ 10 milli-international units per milliliter (mIU/mL).

  3. Number of Seroprotected Subjects Against Poliovirus (Polio) Types 1,2,3 Antigens [ Time Frame: One month post Dose 3 (Month 3 or Month 5) ]
    A seroprotected subject was defined as a subject with anti-Poliovirus 1,2 and 3 antibody titers ≥ 8 effective dose, for 50% of people receiving the vaccine (ED50).

  4. Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP) Antigens [ Time Frame: One month post Dose 3 (Month 3 or Month 5) ]
    A seroprotected subject was defined as a subject with anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).

  5. Number of Subjects With Vaccine Response for Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) [ Time Frame: One month post Dose 3 (Month 3 or Month 5) ]
    Vaccine response was defined as : For initially seronegative subjects (S-), antibody concentration ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) at 1 month after the third dose; For initially seropositive subjects (S+): antibody concentration at 1 month after the third dose ≥ 1 fold increase in the pre-vaccination antibody concentration.


Secondary Outcome Measures :
  1. Anti-D and Anti-T Antibody Concentrations [ Time Frame: One month post Dose 3 (Month 3 or Month 5) ]
    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).

  2. Anti-HBs Antibody Concentrations [ Time Frame: One month post Dose 3 (Month 3 or Month 5) ]
    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).

  3. Anti-Polio Types 1, 2, 3 Antibody Titers [ Time Frame: One month post Dose 3 (Month 3 or Month 5) ]
    Antibody titers were presented as geometric mean titers (GMTs).

  4. Anti-PRP Antibody Concentrations [ Time Frame: One month post Dose 3 (Month 3 or Month 5) ]
    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.

  5. Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations [ Time Frame: One month post Dose 3 (Month 3 or Month 5) ]
    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.

  6. Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN [ Time Frame: One month post Dose 3 (Month 3 or Month 5) ]
    A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.

  7. Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens [ Time Frame: At Month 0 ]
    A seroprotected subject was defined as a subject with anti-Polio type 1, 2 and 3 antibody titers ≥ 8 effective dose, for 50% of people receiving the vaccine (ED50).

  8. Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN [ Time Frame: At Month 0 ]
    A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.

  9. Number of Seroprotected Subjects Against Anti-HBs Antigens [ Time Frame: At Month 0 ]
    A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.

  10. Anti-Polio Types 1, 2 and 3 Antibody Titers [ Time Frame: At Month 0 ]
    Antibody titers were presented as geometric mean titers (GMTs).

  11. Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations [ Time Frame: At Month 0 ]
    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.

  12. Anti-HBs Antibody Concentrations [ Time Frame: At Month 0 ]
    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.

  13. Number of Subjects With Any Solicited Local Symptoms [ Time Frame: During the 4-day (Days 0-3) post-vaccination period after each dose and across doses: Up to Month 2 (Infanrix Hexa 6-10-14 Group) or Month 4 (Infanrix Hexa 2-4-6 Group) ]
    Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of any particular symptom regardless of intensity grade.

  14. Number of Subjects With Solicited General Symptoms [ Time Frame: During the 4-day (Days 0-3) post-vaccination period after each dose and across doses: Up to Month 2 (Infanrix Hexa 6-10-14 Group) or Month 4 (Infanrix Hexa 2-4-6 Group) ]
    Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = incidence of any particular symptom regardless of intensity grade or relationship to study vaccination.

  15. Number of Subjects With Unsolicited Adverse Events (AEs) [ Time Frame: During the 31-day (Days 0-30) post-vaccination period: Up to Month 3 (Infanrix Hexa 6-10-14 Group) or Month 5 (Infanrix Hexa 2-4-6 Group) ]
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

  16. Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (from Month 0 up to Month 3 (Infanrix Hexa 6-10-14 Group) or Month 5 (Infanrix Hexa 2-4-6 Group)) ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.



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Ages Eligible for Study:   6 Weeks to 10 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

All subjects must satisfy ALL the following criteria at study entry:

  • A male or female between, and including, 6 and 10 weeks of age at the time of the first vaccination
  • Documented administration of a hepatitis B vaccine dose at birth
  • Subjects who the investigator believes that their parent(s)/legally acceptable representative(s) [LAR(s)] can and will comply with the requirements of the protocol
  • Written informed consent obtained from the parent(s)/LAR(s) of the subject
  • Healthy subjects as established by medical history and clinical examination before entering into the study
  • Born after a gestation period of at least 36 weeks

Exclusion Criteria:

The following criteria should be checked at the time of study entry. If ANYexclusion criterion applies, the subject must not be included in the study:

  • Child in care
  • Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose, or planned use during the study period
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose
  • Administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, or planned administration during the study period, with the exception of oral human rotavirus (HRV) vaccination which is allowed at any time during the study
  • 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
  • Evidence of previous diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b (Hib) vaccination or disease, with the exception of a birth dose of hepatitis B vaccine and oral poliovirus vaccine (OPV) as per local standard of care
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
  • Family history of congenital or hereditary immunodeficiency
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine
  • Major congenital defects or serious chronic illness
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period
  • Acute disease and/or fever at the time of enrolment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01353703


Locations
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India
GSK Investigational Site
Belgaun, India, 590010
GSK Investigational Site
Chennai, India
GSK Investigational Site
Pune, India, 411018
GSK Investigational Site
Pune, India
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
Additional Information:
Study Data/Documents: Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 111157
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 111157
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 111157
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 111157
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 111157
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 111157
For additional information about this study please refer to the GSK Clinical Study Register

Publications:
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01353703    
Other Study ID Numbers: 111157
2013-003427-10 ( EudraCT Number )
First Posted: May 16, 2011    Key Record Dates
Results First Posted: January 25, 2019
Last Update Posted: January 2, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD is available via the Clinical Study Data Request site (click on the link provided below)
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: https://clinicalstudydatarequest.com/Posting.aspx?ID=4632
Keywords provided by GlaxoSmithKline:
Infanrix hexa™
Primary vaccination
India
combination vaccine
infants
Additional relevant MeSH terms:
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Hepatitis A
Influenza, Human
Hepatitis B
Tetanus
Diphtheria
Poliomyelitis
Hepatitis
Tetany
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Respiratory Tract Infections
Orthomyxoviridae Infections
Respiratory Tract Diseases
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections
Bacterial Infections
Bacterial Infections and Mycoses
Clostridium Infections
Gram-Positive Bacterial Infections
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases