Diphtheria, Pertussis, Tetanus, Hepatitis B, Haemophilus Influenzae Infections
Conditions
Keywords
Vaccination, Immunisation, Virus, Diphtheria, Pertussis, Tetanus, Hepatitis B, Haemophilus Influenzae, Immunity
Brief summary
The aim of this study was to evaluate the immunogenicity and safety of the Quinvaxem vaccine (a liquid combination vaccine against diphtheria, tetanus, B. pertussis, hepatitis B and H. influenzae Type B). Healthy Vietnamese infants received three doses of vaccine at 2, 3 and 4 months of age according to the local Expanded Programme on Immunisation (EPI) schedule
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 2, 3 and 4 months of age
Sponsors
Crucell Holland BV
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Days to 120 Days
Healthy volunteers
Yes
Inclusion criteria
* Infants are at age of DTP vaccination of the local EPI program (60-120 days old) and free from any obvious health problems * Have a normal gestational age (≥ 37 weeks); birth weight \> 2.5 kg * There is no congenital disease detected through interview and clinical examination * Already had or not yet received Hepatitis B vaccination at birth * Do not have dermatological diseases such as eczema, allergies * Parent or legal guardian voluntarily provides consent for their child for participation in the study by signing the informed consent and agrees to comply with all study procedures
Exclusion criteria
* Already vaccinated with DTP vaccine * Have an acute infection at the time of study vaccination * Contraindications to Quinvaxem * Receiving treatment with systemic corticosteroids * Currently participating in another clinical trial * In receipt of a parenteral immunoglobulin preparation and/or blood/blood products since birth * Parents intend to move to another location during the study (the next 12 months)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component | at 5 months (equivalent to 1 month after the third vaccination) | Assessment of the proportion of subjects who have seroconverted to each of the 5 vaccine components (D, T, P, HepB, Hib) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Adverse and Serious Adverse Events | From Day 1 up to 30 days after the third vaccination | Assessment of the proportion of children with adverse events and/or serious adverse events following each Quinvaxem vaccine injection |
Countries
Vietnam
Participant flow
Recruitment details
Participants were recruited at one center in Vietnam First subject first visit (FSFV): April 2010 Last subject last visit (LSLV): April 2011
Participants by arm
| Arm | Count |
|---|---|
| Quinvaxem Quinvaxem : 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 2, 3 and 4 months of age | 131 |
| Total | 131 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Quinvaxem |
|---|---|
| Age, Categorical <=18 years | 131 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Sex: Female, Male Female | 74 Participants |
| Sex: Female, Male Male | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 75 / 131 | 34 / 131 | 25 / 130 |
| serious Total, serious adverse events | 4 / 131 | 6 / 131 | 1 / 130 |
Outcome results
Primary
Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component
Assessment of the proportion of subjects who have seroconverted to each of the 5 vaccine components (D, T, P, HepB, Hib)
Time frame: at 5 months (equivalent to 1 month after the third vaccination)
Population: Analysis population excludes one subject excluded as a protocol violator
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Quinvaxem | Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component | % of subjects with anti-diphtheria >=0.1 IU/mL | 93.1 percentage of subjects |
| Quinvaxem | Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component | % of subjects with anti-pertussis >=20 EU/mL | 99.2 percentage of subjects |
| Quinvaxem | Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component | % of subjects with anti-tetanus >=0.1 IU/mL | 98.5 percentage of subjects |
| Quinvaxem | Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component | % of subjects with anti-hepatitis B >=10 mIU/mL | 93.1 percentage of subjects |
| Quinvaxem | Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component | % of subjects with anti-PRP>=0.15 mcg/mL | 100 percentage of subjects |
Primary
Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component
Assessment of the proportion of subjects who have seroconverted to each of the 5 vaccine components (D, T, P, HepB, Hib)
Time frame: at 14 months (equivalent to 12 months after the first vaccination
Population: Analysis population excludes one subject excluded as a protocol violator and additionally at 14 months one lost to follow up
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Quinvaxem | Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component | % of subjects with anti-diphtheria >=0.1 IU/mL | 88.4 percentage of subjects |
| Quinvaxem | Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component | % of subjects with anti-pertussis >=20 EU/mL | 49.6 percentage of subjects |
| Quinvaxem | Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component | % of subjects with anti-tetanus >=0.1 IU/mL | 82.2 percentage of subjects |
| Quinvaxem | Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component | % of subjects with anti-hepatitis B >=10 mIU/mL | 76.7 percentage of subjects |
| Quinvaxem | Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component | % of subjects with anti-PRP >=0.15 mcg/mL | 97.7 percentage of subjects |
Secondary
Safety: Adverse and Serious Adverse Events
Assessment of the proportion of children with adverse events and/or serious adverse events following each Quinvaxem vaccine injection
Time frame: From Day 1 up to 30 days after the third vaccination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Quinvaxem | Safety: Adverse and Serious Adverse Events | Injection site swelling | 5.6 Number of children with AE per 100 doses |
| Quinvaxem | Safety: Adverse and Serious Adverse Events | Injection site redness | 2.8 Number of children with AE per 100 doses |
| Quinvaxem | Safety: Adverse and Serious Adverse Events | Injection site pain | 4.1 Number of children with AE per 100 doses |
| Quinvaxem | Safety: Adverse and Serious Adverse Events | Fever (>=38 deg C) | 18.4 Number of children with AE per 100 doses |
| Quinvaxem | Safety: Adverse and Serious Adverse Events | Rash | 0.3 Number of children with AE per 100 doses |
| Quinvaxem | Safety: Adverse and Serious Adverse Events | Loss of appetite | 2.6 Number of children with AE per 100 doses |
| Quinvaxem | Safety: Adverse and Serious Adverse Events | Vomiting | 1.0 Number of children with AE per 100 doses |
| Quinvaxem | Safety: Adverse and Serious Adverse Events | Diarrhea | 3.0 Number of children with AE per 100 doses |
| Quinvaxem | Safety: Adverse and Serious Adverse Events | Irritability | 7.9 Number of children with AE per 100 doses |
| Quinvaxem | Safety: Adverse and Serious Adverse Events | Abnormal crying | 0 Number of children with AE per 100 doses |
| Quinvaxem | Safety: Adverse and Serious Adverse Events | Persistent crying | 0.5 Number of children with AE per 100 doses |
| Quinvaxem | Safety: Adverse and Serious Adverse Events | Drowsiness | 0.5 Number of children with AE per 100 doses |