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

Hepatitis B Clinical Trial

Official title:

Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Infanrix Hexa™ Vaccine in Healthy Infants in India

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01353703
• Other study ID #: 111157
• Secondary ID: 2013-003427-10
• Status: Completed
• Phase: Phase 3
• Start date: April 16, 2012
• Est. completion date: February 25, 2013

Study information

• Verified date: December 2019
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: February 25, 2013
• Est. primary completion date: February 25, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks to 10 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Acellular Pertussis
• Diphtheria
• Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b Vaccines
• Haemophilus Influenzae Type b
• Hepatitis
• Hepatitis A
• Hepatitis B
• Influenza, Human
• Poliomyelitis
• Tetanus

Intervention

Biological:
• Infanrix hexa™
Intramuscular, three doses

Locations

Country	Name	City	State
India	GSK Investigational Site	Belgaun
India	GSK Investigational Site	Chennai
India	GSK Investigational Site	Pune
India	GSK Investigational Site	Pune

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

India, 

References & Publications (1)

Lalwani SK et al. (2016) Immunogenicity and safety of 3-dose primary vaccination with combined DTPa-HBV-IPV/Hib in Indian infants. Hum Vaccin Immunother. 15:0. [Epub ahead of print].

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens	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).	One month post Dose 3 (Month 3 or Month 5)
Primary	Number of Seroprotected Subjects Against Hepatitis B (HBs)	A seroprotected subject was defined as a vaccinated subject with anti-HBS antibody concentration = 10 milli-international units per milliliter (mIU/mL).	One month post Dose 3 (Month 3 or Month 5)
Primary	Number of Seroprotected Subjects Against Poliovirus (Polio) Types 1,2,3 Antigens	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).	One month post Dose 3 (Month 3 or Month 5)
Primary	Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP) Antigens	A seroprotected subject was defined as a subject with anti-PRP antibody concentration = 0.15 micrograms per milliliter (µg/mL).	One month post Dose 3 (Month 3 or Month 5)
Primary	Number of Subjects With Vaccine Response for Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)	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.	One month post Dose 3 (Month 3 or Month 5)
Secondary	Anti-D and Anti-T Antibody Concentrations	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).	One month post Dose 3 (Month 3 or Month 5)
Secondary	Anti-HBs Antibody Concentrations	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).	One month post Dose 3 (Month 3 or Month 5)
Secondary	Anti-Polio Types 1, 2, 3 Antibody Titers	Antibody titers were presented as geometric mean titers (GMTs).	One month post Dose 3 (Month 3 or Month 5)
Secondary	Anti-PRP Antibody Concentrations	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.	One month post Dose 3 (Month 3 or Month 5)
Secondary	Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.	One month post Dose 3 (Month 3 or Month 5)
Secondary	Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN	A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations = 5 EL.U/mL.	One month post Dose 3 (Month 3 or Month 5)
Secondary	Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens	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).	At Month 0
Secondary	Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN	A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations = 5 EL.U/mL.	At Month 0
Secondary	Number of Seroprotected Subjects Against Anti-HBs Antigens	A seroprotected subject was defined as a subject with anti-HBs antibody concentrations = 10 mIU/mL.	At Month 0
Secondary	Anti-Polio Types 1, 2 and 3 Antibody Titers	Antibody titers were presented as geometric mean titers (GMTs).	At Month 0
Secondary	Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.	At Month 0
Secondary	Anti-HBs Antibody Concentrations	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.	At Month 0
Secondary	Number of Subjects With Any Solicited Local Symptoms	Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of any particular symptom regardless of intensity grade.	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)
Secondary	Number of Subjects With Solicited General Symptoms	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.	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)
Secondary	Number of Subjects With Unsolicited Adverse Events (AEs)	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.	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)
Secondary	Number of Subjects With Serious Adverse Events (SAEs)	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.	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))

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