CompletedNCT01357720Updated Sep 9, 2013Results posted

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

A Phase 4 interventional study of Quinvaxem and Quinvaxem/Tritanrix in Diphtheria, Pertussis and Tetanus, sponsored by Crucell Holland BV. Completed at 1 site in Philippines. Open to participants aged 42 Days to 64 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-09-09.

Sponsored by Crucell Holland BV · Phase 4, Interventional, and Prevention

Phase: Phase 4
Study type: Interventional
Enrollment: 400
Allocation: Randomized
Ages: 42 Days to 64 Days
Sex: All

Study 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.

Conditions studied

Diphtheria
Pertussis
Tetanus
Hepatitis B
Haemophilus Infections

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Keywords

Vaccination
Immunisation
Virus
Diphtheria
Pertussis
Tetanus
Hepatitis B
Haemophilus Influenzae
Immunity

In context

Hepatitis B

1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.

This study's enrollment of 400 is above the median of 120 across 1,187 interventional studies indexed under Hepatitis B.

Browse Hepatitis B studies →

Lead sponsor

Crucell Holland BV is the lead sponsor of 35 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 42 Days to 64 Days
Sexes eligible: All
Accepts 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

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

Study design

Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Care provider)
Enrollment: 400 participants (actual)

Study arms

Experimental
Quinvaxem
Biological: Quinvaxem
Active comparator
Tritanrix Hib/HepB + Quinvaxem
Biological: Quinvaxem/Tritanrix

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

What researchers measure

Primary outcomes

Seroprotection Rate: Anti-PRP Antibodies
Percentage of subjects with an anti-PRP titer ≥0.15 µg/mL (i.e. seroprotection rate)
Time frame: 1 month after the third vaccination
Seroprotection Rate: Anti-hepatitis B Surface Antibodies
Percentage of subjects with an anti-hepatitis B surface antibody titer ≥10 IU/L (i.e. seroprotection rate)
Time frame: 1 month after the third vaccination
Seroprotection Rate: Anti-diphtheria Toxoid Antibodies
Percentage of subjects with antibody levels against diphtheria toxoid ≥0.1 IU/mL (i.e. seroprotection rate)
Time frame: 1 month after the third vaccination
Seroprotection Rate: Anti-tetanus Toxoid Antibodies
Percentage of subjects with antibody levels against tetanus toxoid ≥0.1 IU/mL (i.e. seroprotection rate)
Time frame: 1 month after the third vaccination
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

Results

Posted May 22, 2013

Participant flow

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

Participant flow — Overall Study
Milestone	Quinvaxem	Tritanrix Hib/HepB + Quinvaxem
Started	200	200
Completed	198	195
Not completed	2	5

Outcome measures

PrimarySeroprotection Rate: Anti-PRP Antibodies

Percentage of subjects with an anti-PRP titer ≥0.15 µg/mL (i.e. seroprotection rate)

Time frame:: 1 month after the third vaccination
Reported as:: Number · percentage of subjects

Seroprotection Rate: Anti-PRP Antibodies
percentage of subjects	Quinvaxem	Tritanrix Hib/HepB + Quinvaxem
Seroprotection Rate: Anti-PRP Antibodies	100 (98.1 to 100)	100 (98.1 to 100)

PrimarySeroprotection Rate: Anti-hepatitis B Surface Antibodies

Percentage of subjects with an anti-hepatitis B surface antibody titer ≥10 IU/L (i.e. seroprotection rate)

Time frame:: 1 month after the third vaccination
Reported as:: Number · percentage of subjects

Seroprotection Rate: Anti-hepatitis B Surface Antibodies
percentage of subjects	Quinvaxem	Tritanrix Hib/HepB + Quinvaxem
Seroprotection Rate: Anti-hepatitis B Surface Antibodies	94.9 (90.9 to 97.6)	97.4 (94.1 to 99.2)

PrimarySeroprotection Rate: Anti-diphtheria Toxoid Antibodies

Percentage of subjects with antibody levels against diphtheria toxoid ≥0.1 IU/mL (i.e. seroprotection rate)

Time frame:: 1 month after the third vaccination
Reported as:: Number · percentage of subjects

Seroprotection Rate: Anti-diphtheria Toxoid Antibodies
percentage of subjects	Quinvaxem	Tritanrix Hib/HepB + Quinvaxem
Seroprotection Rate: Anti-diphtheria Toxoid Antibodies	99.5 (97.2 to 100)	100 (98.1 to 100)

PrimarySeroprotection Rate: Anti-tetanus Toxoid Antibodies

Percentage of subjects with antibody levels against tetanus toxoid ≥0.1 IU/mL (i.e. seroprotection rate)

Time frame:: 1 month after the third vaccination
Reported as:: Number · percentage of subjects

Seroprotection Rate: Anti-tetanus Toxoid Antibodies
percentage of subjects	Quinvaxem	Tritanrix Hib/HepB + Quinvaxem
Seroprotection Rate: Anti-tetanus Toxoid Antibodies	100 (98.2 to 100)	100 (98.1 to 100)

PrimarySeroprotection 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
Reported as:: Number · percentage of subjects

Seroprotection Rate: Anti-B. Pertussis Antibodies
percentage of subjects	Quinvaxem	Tritanrix Hib/HepB + Quinvaxem
Seroprotection Rate: Anti-B. Pertussis Antibodies	99.0 (96.4 to 99.9)	100 (98.1 to 100)

Adverse events

Collected over Solicited local and systemic AEs were collected on the day of vaccination, and for the four days after the day of each vaccination. Unsolicited AEs were collected at each study visit up to Day 85.. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Quinvaxem	—	0/200 (0%)	180/200 (90%)
Tritanrix Hib/HepB + Quinvaxem	—	2/200 (1%)	180/200 (90%)

Most frequent serious events

Most frequent serious events
Event	Quinvaxem	Tritanrix Hib/HepB + Quinvaxem
Viral encephalitisInfections and infestations	0/200	1/200
Idiopathic thrombocytopenic purpuraBlood and lymphatic system disorders	0/200	1/200
PneumoniaInfections and infestations	0/200	1/200
Respiratory failureRespiratory, thoracic and mediastinal disorders	0/200	1/200

Most frequent other events

Most frequent other events
Event	Quinvaxem	Tritanrix Hib/HepB + Quinvaxem
Injection site painGeneral disorders	137/200	157/200
PyrexiaGeneral disorders	88/200	95/200
Injection site indurationGeneral disorders	74/200	82/200
Injection site erythemaGeneral disorders	59/200	54/200
Upper respiratory tract infectionInfections and infestations	46/200	54/200
NasopharyngitisInfections and infestations	7/200	9/200
RhinitisInfections and infestations	7/200	7/200
PneumoniaInfections and infestations	7/200	3/200

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Quinvaxem	Tritanrix Hib/HepB + Quinvaxem	Total
<=18 years	200	200	400
Between 18 and 65 years	0	0	0
>=65 years	0	0	0

Age Continuous
Age Continuous(weeks)	Quinvaxem	Tritanrix Hib/HepB + Quinvaxem	Total
Mean	6.8 ± 0.91	6.7 ± 0.86	6.7 ± 0.89

Sex: Female, Male
Sex: Female, Male(Participants)	Quinvaxem	Tritanrix Hib/HepB + Quinvaxem	Total
Female	101	105	206
Male	99	95	194

Study locations

1 site

Research Institute for Tropical Medicine
Muntinlupa City, Philippines

References and documents

Publications

Capeding MR, Jica C, Macura-Biegun A, Rauscher M, Alberto E. Interchangeability of Quinvaxem during primary vaccination schedules: results from a phase IV, single-blind, randomized, controlled, single-center, non-inferiority study. Vaccine. 2014 Feb 7;32(7):888-94. doi: 10.1016/j.vaccine.2013.10.059. Epub 2013 Oct 29. PubMed 24176498 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 9, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01357720
Lead sponsor: Crucell Holland BV
Responsible party: Sponsor
First posted: May 23, 2011
Start date: May 2011
Primary completion: Sep 2011
Completion: Sep 2011
Results posted: May 22, 2013
Last update: Sep 9, 2013

Study contacts

Maria RZ Capeding, MD

principal investigator · Research Institute for Tropical Medicine (RITM)

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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