> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/trial/a-phase-3-study-of-bibp-diphtheria-tetanus-and-acellular-eb67211b-e1c8-496f-b12f-7f021c930777
> Record changed: 2026-10-13

# A Phase 3 Study of BIBP Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed

NCT05091619

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05091619)

Phase

Phase 3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05091619)

Recruitment status

Active, not recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05091619)

Participants

2,898

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05091619)

Lead sponsor

China National Biotec Group Company Limited

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05091619)

Start date

2021-10-22

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05091619)

Number of sites

4

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05091619)

## Title and summary

**Summary**

The study will evaluate the safety, immunogenicity，immune persistence and lot-to-lot consistency of Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed, (DTacP) including 2 parts: PART 1 will evaluate the safety and immunogenicity of DTacP in health infants aged 2 months and 3 months compared with an adsorption Tetanus-diphtheria-acellular Pertussis (DTaP) Vaccine and Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine (PENTAXIM)，compare the safety and immunogenicity of DTacP with different immunization schedules, and observe the immune persistence. PART 2 will evaluate the lot-to-lot consistency of DTacP in health infants aged 3 months with the 3-dose schedule of 3-4-5 month.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05091619)

**Acronym**

DTaP

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05091619)

**Short title**

A Phase 3 Study of BIBP Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05091619)

**Official title**

A Randomized, Blinded, Parallel Controlled Phase 3 Clinical Study to Evaluate the Safety and Immunogenicity of the Diphtheria, Tetanus and Three-components Acellular Pertussis Combined Vaccine, Adsorbed in Healthy Infants at the Age of 2 Months and 3 Months

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05091619)

## Status and phase

**Control arm**

Active comparator

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05091619)

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05091619)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05091619)

**Recruitment status**

Active, not recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05091619)

**Phase**

Phase 3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05091619)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05091619)

## Dates

**Completion date**

2027-09-22

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05091619)

**First posted**

2021-10-25

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05091619)

**Registry last updated**

2025-09-15

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05091619)

**Primary completion date**

2024-01-22

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05091619)

**Start date**

2021-10-22

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05091619)

## Size and sites

**Actual participants**

2,898

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05091619)

**Participants**

2,898

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05091619)

**Participant count basis**

Actual

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05091619)

**Protocol amendments**

2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05091619)

**Number of sites**

4

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05091619)

## Sponsor and oversight

**Data monitoring committee**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05091619)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05091619)

**Lead sponsor**

China National Biotec Group Company Limited

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05091619)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05091619)

## Identifiers

**Registry ID**

NCT05091619

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05091619)

**ClinicalTrials.gov ID**

NCT05091619

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05091619)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05091619)

## Study design

**Allocation**

Randomised

**Model**

Parallel groups

**Purpose**

Prevention

**Masking**

Triple masking

**Masked roles**

Participants, Investigators, Outcome assessors

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05091619)

## Outcomes

### Primary outcomes

1. The seroconversion rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody  
Timeframe: 1 month after Dose 3  
seroconversion is defined as post-third dose antibody concentrations ≥ protective antibody concentration if pre-vaccination concentration is \\< protective antibody concentration, or ≥ 4 x protective antibody concentration if pre-vaccination concentrations ≥ protective antibody concentration.
2. Geometric Mean Concentrations (GMCs) of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody  
Timeframe: 1 month after Dose 3  
As measured at the central laboratory
3. Percentage of participants reporting local reactions  
Timeframe: Day 7 post-each dose  
As elicited by investigational site staff
4. Percentage of participants reporting systemic events  
Timeframe: Day 7 post-each dose  
As elicited by investigational site staff
5. Percentage of participants reporting adverse events  
Timeframe: within 30 days post-each dose  
As elicited by investigational site staff

### Secondary outcomes

1. The seropositivity rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody  
Timeframe: Day 30 post-dose 3  
Seropositivity is defined as post-3 dose antibody concentrations ≥ protective antibody concentration
2. Geometric Mean Concentrations (GMCs) of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody  
Timeframe: before dose 4 at 18 months old(booster)  
As measured at the central laboratory
3. The seropositivity rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody  
Timeframe: before dose 4 at 18 months old(booster)  
Seropositivity is defined as antibody concentrations ≥ protective antibody concentration
4. Geometric Mean Concentrations (GMCs) of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody  
Timeframe: Day 30 post-dose 4 at 18 months old(booster)  
As measured at the central laboratory
5. The seropositivity rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody  
Timeframe: Day 30 post-dose 4 at 18 months old(booster)  
eropositivity is defined as antibody concentrations ≥ protective antibody concentration

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05091619)

## Eligibility

**Sex**

All

**Age groups**

Children

**Minimum age**

2 Months

**Maximum age**

3 Months

**Healthy volunteers**

Yes

### Inclusion criteria

- Healthy subjects aged 2months (60-89 days) and 3months (90-119 days) ；
- Willing to provide proof of identity
- Subjects aged 2 months have not been vaccinated with DTaP, IPV, Hib, or 13-valent pneumococcal polysaccharide conjugate vaccine;
- Subjects of 3 months have not been inoculated with DTaP vaccine, and IPV (only group A3）；
- Subjects'guardians or trustees are able to understand and sign the informed consent voluntarily, comply with the requirements of the clinical study plan.

### Exclusion criteria

- With temperature >37.0°C on axillary setting before vacciation;
- With a medical history of diphtheria, pertussis or tetanus;
- Had contact with individuals with confirmed pertussis, diphtheria and tetanus diseases in their families in the past 30 days;
- Premature birth (delivery before the 37th week of pregnancy)or low birth weight (birth weight< <2500g);
- History of dystocia, suffocation rescue, neurological damage;
- With congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
- History of epilepsy, convulsions or convulsions, or have a family history of mental illness;
- History of abnormal blood coagulation (such as coagulation factor deficiency, coagulopathy);
- Had received immune enhancement or inhibitor therapy (continuous oral or instillation for more than 14 days);
- History of severe allergic reactions to vaccination, such as difficulty breathing, urticaria;
- Any prior administration of blood products in last 3 month;
- Any prior administration of attenuated live vaccine in last 14 days;
- Any prior administration of subunit or inactivated vaccines in last 7 days;
- Plans to participate in or is participating in any other drug clinical study;
- Has any other factors judged by investigators that make them unfit to participate in the clinical trial

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05091619)

## Sites

- Neihuang County Center for Disease Control and PreventionAnyang, China
- Wen County Center for Disease Control and PreventionJiaozuo, China
- Wuyang County Center for Disease Control and PreventionLuohe, China
- Yanjin County Center for Disease Control and PreventionXinxiang, China

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05091619)

## Related records

### Drugs (3)

- [Diphtheria toxoid](https://trialight.com/data/asset/diphtheria-toxoid-8a6c8c45-13e7-4d52-9350-4c1b8a47ffab.md)
- Haemophilus influenzae type B strain 20752 capsular polysaccharide tetanus toxoid conjugate antigen
- [Poliovirus vaccine inactivated](https://trialight.com/data/asset/poliovirus-vaccine-inactivated-73d8bd8f-cda2-4090-885b-f54c53ea52ef.md)

### Collaborators (1)

- Beijing Institute of Biological Products Co Ltd.

### Lead sponsors (1)

- [China National Biotec Group Company Limited](https://trialight.com/data/company/china-national-biotec-group-company-limited-e14db185-d2b3-4b40-8f44-7e119dd3c717.md)

### Conditions (3)

- [Diphtheria](https://trialight.com/data/condition/diphtheria-1a3815ca-3ad9-5b77-b86f-11d55e29e9fa.md)
- [Pertussis](https://trialight.com/data/condition/pertussis-810232d3-8d41-590a-8f38-1061f23d3a9f.md) Primary condition
- [Tetanus](https://trialight.com/data/condition/tetanus-a589c209-81c5-56e6-8a55-6d96fedb2c61.md)

---

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