Study to Assess if Quinvaxem Can be Interchanged With Other Pentavalent Vaccines During Standard Childhood Vaccination

A Phase IV, Single-blind, Randomized, Controlled, Monocentric Study to Assess the Interchangeability of Quinvaxem (DTwP-HepB-Hib) as the 2nd and 3rd Dose After Initial Vaccination With Tritanrix HB+Hib (DTwP-HepB/Hib) With Respect to Safety and Immunogenicity in Healthy Infants at 6, 10 and 14 Weeks of Age

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01357720

Enrollment

400

Registered

2011-05-23

Start date

2011-05-31

Completion date

2011-09-30

Last updated

2013-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diphtheria, Pertussis, Tetanus, Hepatitis B, Haemophilus Infections

Keywords

Vaccination, Immunisation, Virus, Diphtheria, Pertussis, Tetanus, Hepatitis B, Haemophilus Influenzae, Immunity

Brief summary

This is a study to show that vaccination with 1 dose of Tritanrix HB+Hib followed by Quinvaxem vaccine as the 2nd and 3rd dose is not inferior to vaccination with Quinvaxem for all 3 doses, with respect to protection against all antibodies (anti-hepatitis B surface antibodies, anti-polyribosyl ribitol phosphate (PRP), anti-diphtheria, anti-tetanus and anti-Bordetella pertussis) 1 month after completion of the 6-10-14 week vaccination course.

Interventions

BIOLOGICALQuinvaxem

A single dose (0.5 mL) of Quinvaxem contains: diphtheria antitoxin (\>= 30 IU), tetanus antitoxin (\>= 60 IU), whole-cell inactive pertussis bacteria (\>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen One dose of Quinvaxem given at Weeks 6, 10 and 14

BIOLOGICALQuinvaxem/Tritanrix

A single dose (0.5 mL) of Quinvaxem contains: diphtheria antitoxin (\>= 30 IU), tetanus antitoxin (\>= 60 IU), inactive pertussis bacteria (\>= 4 IU), 10 mcg Hib polysaccharide conjugate (approx. 25 mcg tetanus toxoid), 10 mcg Hepatitis B surface antigen One dose of Quinvaxem given at Weeks 6, 10 and 14

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Caregiver)

Eligibility

Sex/Gender

ALL

Age

42 Days to 64 Days

Healthy volunteers

Yes

Inclusion criteria

* A male or female between, and including, 42 and 64 days of age at the time of the first vaccination * Written informed consent obtained from parents/legal guardian of the subject * Free of obvious health problems as established by medical history and/or clinical examination before entering the study * Hepatitis B vaccination at birth (within 48 hours) Available for all scheduled study visits

Exclusion criteria

* Use of any investigational drug or any investigational vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period and safety follow-up * Planned administration of a vaccine not foreseen by the study protocol * Known or suspected impairment of immune function, known Human immunodeficiency virus (HIV)-positivity, receiving immunosuppressive therapy, or having received systemic immunosuppressive therapy within 1 month prior to study entry (note: inhaled and topical steroids are allowed) * Administration of parenteral immunoglobulin preparation and/or blood products since birth * Previous vaccination against Haemophilus influenzae type b (Hib) and/or diphtheria, tetanus, pertussis (DTP) * History of anaphylaxis, or any serious vaccine reaction, or allergy to any vaccine component or to products containing mercury compounds, such as sodium ethylmercuro-thiosalicylate * Significant acute infection * Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives * Participation in another clinical study

Design outcomes

Primary

Measure	Time frame	Description
Seroprotection Rate: Anti-PRP Antibodies	1 month after the third vaccination	Percentage of subjects with an anti-PRP titer ≥0.15 µg/mL (i.e. seroprotection rate)
Seroprotection Rate: Anti-hepatitis B Surface Antibodies	1 month after the third vaccination	Percentage of subjects with an anti-hepatitis B surface antibody titer ≥10 IU/L (i.e. seroprotection rate)
Seroprotection Rate: Anti-diphtheria Toxoid Antibodies	1 month after the third vaccination	Percentage of subjects with antibody levels against diphtheria toxoid ≥0.1 IU/mL (i.e. seroprotection rate)
Seroprotection Rate: Anti-tetanus Toxoid Antibodies	1 month after the third vaccination	Percentage of subjects with antibody levels against tetanus toxoid ≥0.1 IU/mL (i.e. seroprotection rate)
Seroprotection Rate: Anti-B. Pertussis Antibodies	1 month after the third vaccination	Percentage of subjects with an anti-B. pertussis antibody titer ≥20 EU/mL or a 4-fold increase over baseline (i.e. seroconversion rate)

Countries

Philippines

Participant flow

Recruitment details

Participants were recruited at two vaccination sites in the Philippines: First subject first visit (FSFV): 30 May 2011 Last subject last visit (LSLV): 30 September 2011

Participants by arm

Arm	Count
Quinvaxem Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem	200
Tritanrix Hib/HepB + Quinvaxem Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem	200
Total	400

Baseline characteristics

Characteristic	Quinvaxem	Tritanrix Hib/HepB + Quinvaxem	Total
Age, Categorical <=18 years	200 Participants	200 Participants	400 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	0 Participants	0 Participants	0 Participants
Age Continuous	6.8 weeks STANDARD_DEVIATION 0.91	6.7 weeks STANDARD_DEVIATION 0.86	6.7 weeks STANDARD_DEVIATION 0.89
Sex: Female, Male Female	101 Participants	105 Participants	206 Participants
Sex: Female, Male Male	99 Participants	95 Participants	194 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	180 / 200	180 / 200
serious Total, serious adverse events	0 / 200	2 / 200

Outcome results

Primary

Seroprotection Rate: Anti-B. Pertussis Antibodies

Percentage of subjects with an anti-B. pertussis antibody titer ≥20 EU/mL or a 4-fold increase over baseline (i.e. seroconversion rate)

Time frame: 1 month after the third vaccination