Study to Evaluate Antibody Persistence in Children Previously Vaccinated With Infanrix Hexa™ or Infanrix-IPV/Hib™

Conditions

Acellular Pertussis, Diphtheria, Diphtheria-Tetanus-aPertussis-Poliomyelitis-Haemophilus Influenzae Type b Vaccines, Haemophilus Influenzae Type b, Hepatitis B, Poliomyelitis, Tetanus

Keywords

Infanrix-IPV/Hib, Long-term follow up, Persistence, Infanrix hexa

Brief summary

The aim of this study is to assess antibody persistence in infants who received three doses of Infanrix hexa™ (DTPa-HBV-IPV/Hib) or Infanrix-IPV/Hib™ (DTPa-IPV/Hib) at 3, 5 and 11 months of age in study NCT00307034.

Related papers

No related papers found yet.

Interventions

PROCEDUREBlood Sampling

A blood sample will be taken at 5 years of age, after vaccination in the primary study.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

5 Years to 6 Years

Healthy volunteers

Yes

Inclusion criteria

* Subjects who had received 3 doses of Infanrix hexa™ or Infanrix-IPV/Hib™ in study NCT00307034. * Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) LAR(s) can and will comply with the requirements of the protocol. * A male or female subject aged 5 years at the time of study entry. * 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.

Exclusion criteria

* Child in care. * 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. * Use of any investigational or non-registered product within 30 days prior to blood sampling. * Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, and Hib vaccination or disease since the study NCT00307034, with the exception of hepatitis B vaccination in the DTPa-IPV/Hib group. * Administration of immunoglobulins and/or any blood products within the 3 months prior to blood sampling. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * Family history of congenital or hereditary immunodeficiency.

Design outcomes

Primary

Measure	Time frame	Description
Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T).	At Day 0	A seroprotected subject is a subject with anti-D/anti-T antibody concentrations greater than (≥) or equal to 0.1 international units per milliliter (IU/mL)
Concentrations of Antibodies Against Anti-D and Anti-T	At Day 0	Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL).
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Antifilamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations ≥5 ELISA Units Per Milliliter (EL.U/mL).	At Day 0	Cut-off values assessed were greater than or equal to 5 ELISA units per millilitre (EL.U/mL) in the sera of subjects seronegative before vaccination.
Concentrations of Antibodies Against Anti-PT, Anti-FHA and Anti-PRN.	At Day 0	Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL).
Number of Seroprotected Subjects Against Anti-hepatitis B Surface Antigen (Anti-HBs).	At Day 0	Seroprotection = anti-HBs antibody concentration ≥ 10 milli-international units per milliliter (mIU/mL).
Concentrations of Antibodies Against Anti-HBs.	At Day 0	Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL).
Number of Seroprotected Subjects Against Anti-polyribosyl Ribitol Phosphate (Anti-PRP).	At Day 0	A seroprotected subject is a subject with anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (μg/mL)
Concentrations of Antibodies Against Anti-PRP.	At Day 0	Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per millilitre (μg/mL).
Number of Subjects With Serious Adverse Events (SAEs).	During the entire study period (up to Day 46)	Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Number of Subjects With Anti-HBs Antibody Concentrations ≥ 6.2 mIU/mL	At Day 0	Cut-off values assessed were greater than or equal to 6.2 milliinternational units per millilitre ( mIU/mL) in the sera of subjects seronegative before vaccination.

Countries

Norway, Sweden

Participant flow

Pre-assignment details

During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

Participants by arm

Arm	Count
Infanrix Hexa Group Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.	12
Infanrix-IPV/Hib Group Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.	46
Total	58

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Blood sample not drawn	0	1

Baseline characteristics

Characteristic	Infanrix Hexa Group	Infanrix-IPV/Hib Group	Total
Age, Continuous	5.0 Years STANDARD_DEVIATION 0	5.0 Years STANDARD_DEVIATION 0	5.0 Years STANDARD_DEVIATION 0
Sex: Female, Male Female	9 Participants	14 Participants	23 Participants
Sex: Female, Male Male	3 Participants	32 Participants	35 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 0	0 / 0
serious Total, serious adverse events	0 / 12	0 / 46

Outcome results

Primary

Concentrations of Antibodies Against Anti-D and Anti-T

Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL).

Time frame: At Day 0