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Completed

NCT Number: NCT01580033

Phase 3 Study of A Group A, C Polysaccharide Meningococcal and Type b Haemophilus Influenzal Conjugate Vaccine

Haemophilus influenzae is an important pathogen which can cause primary infection and respiratory viral infection in infants and leaded to secondary infections. The infection of haemophilus is a major cause of morbidity and mortality in infants and children. At present, the developed conjugant Hib vaccine is proved to be safe and effective. Because Hib vaccine can prevent meningitis, pneumonia, epiglottis inflammation and other serious infection caused by Hib bacteria, the WHO suggested that Hib vaccine should be included in the infant's normal immune programming.

Since the use of meningitis aureus polysaccharide vaccine, incidence of a disease in recent years is declined and maintain to the level of 0.5 per 1/100 thousand. But meningitis aureus polysaccharide vaccine with a relatively poor immune response in the infants under the age of two, and the remaining 60% with a low antibody level and a short duration.

The immunogenicity and safety of this vaccine has been proved in older children aged 6-23 months and 2-5 years. And in the phase I study which was conducted in February, 2012, the safety profile of this vaccine is proved to be acceptable in infants aged 3-5 months. The phase III study is aimed to further evaluate the safety and the immunization of the vaccine. The objective of this study is to evaluate the safety of the group A, C polysaccharide meningococcal and type b haemophilus influenzal conjugate vaccine.

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Key information

Age range

3 month–5 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Funing county Center for Disease Control and Prevention

Yancheng, Jiangsu, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy subjects aged 3 to 5 months, normal intelligence.
  • The subjects' guardians are able to understand and sign the informed consent.
  • Healthy subjects confirmed by medical history questioning, physical examination and clinical decision and in accordance with vaccination requirements of the investigational vaccine.
  • Subjects who can comply with the requirements of the clinical trial program according to the researcher's views.
  • Subjects who have never received group A, C polysaccharide meningococcal vaccine and type b haemophilus Influenzal vaccine.
  • Subjects with temperature<=37°C on axillary setting.

Exclusion criteria

for the first vaccination:

  • Subject who has a medical history of Meningitis;
  • Subject who has a medical history of any of the following: allergies, seizures, epilepsy, encephalopathy history and so on;
  • Subject who is allergic with tetanus toxoid components;
  • Subject suffering from thrombocytopenia or other coagulation disorder may lead to contraindication to intramuscular injection;
  • Subject who has a history of allergic reactions;
  • Any known immunological dysfunction;
  • Had received gamma globulin or immune globulin, in the past two weeks
  • Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws
  • Any acute infections in last 7 days
  • Any prior administration of immunodepressant or corticosteroids in last 6month
  • Any prior administration of other research medicines in last 1 month
  • Any prior administration of attenuated live vaccine in last 28 days
  • Any prior administration of subunit or inactivated vaccines in last 14 days, such as pneumococcal vaccine
  • Subject suffering from congenital malformations, developmental delay or serious chronic disease;
  • Any acute infections
  • Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives

Exclusion criteria

for the second or third vaccination:

  • Had any Grade 3 or Grade 4 adverse reactions or events associated with investigational vaccine occurred since the vaccination
  • Any situation meets the exclusion criteria for first dose;
  • Any condition the investigator believed may affect the evaluation of the vaccine.

Treatment and study plan

A+C+hib Conjugate Vaccine

Biological

The group A, C polysaccharide meningococcal and type b haemophilus influenzal conjugate vaccine (Wuxi Royal Biological Co., LTD, 20110101) will be administered on one arm, intramuscularly, per 0.5ml dose

Placebo

Biological

Placebo will be administered intramuscularly on the other arm, intramuscularly, per 0.5ml dose

A+C Vaccine

Biological

The group A, C polysaccharide meningococcal vaccine (Yunnan Walvax Biotechnology Co., LTD, 20101202) will be administered intramuscularly on one arm, per 0.5ml dose

Hib vaccine

Biological

The type b haemophilus influenzal vaccine (Sanofi Pasteur Limited) will be administered intramuscularly on the other arm, per 0.5ml dose

Primary outcomes

  1. The seroconversion rate of antibody against group A, C polysaccharide meningitis in infants aged 3-5 months

    Time frame: 4 weeks (28±3 days) after the infant series

    the seroconversion rate of antibody against group A, C polysaccharide meningitis in infants aged 3-5 months when measured 4 weeks (28±3 days) after the infant series (three doses, 28 day apart).

  2. The seroconversion rate of antibody against type b haemophilus influenza in infants aged 3-5 months

    Time frame: 4 weeks (28±3 days) after the infant series

    the seroconversion rate of antibody against type b haemophilus Influenza in infants aged 3-5 months when measured 4 weeks (28±3 days) after the infant series (three doses, 28 day apart)

Secondary outcomes

  1. adverse reactions after the first vaccination in infants aged 3-5 months

    Time frame: 7 days after the first vaccination

    adverse reactions of the investigational vaccines in healthy infants aged 3-5 months for 7 days after the first vaccination

  2. adverse reactions after the second vaccination in infants aged 3-5 months

    Time frame: 7 days after the second vaccination

    adverse reactions of the investigational vaccines in healthy infants aged 3-5 months for 7 days after the second vaccination

  3. adverse reactions after the third vaccination in infants aged 3-5 months

    Time frame: 7 days after the third vaccination

    adverse reactions of the investigational vaccines in healthy infants aged 3-5 months for 7 days after the third vaccination

  4. GMT of antibody against group A, C polysaccharide meningitis in infants aged 3-5 months

    Time frame: 4 weeks (28±3 days) after the infant series

    GMT of antibody against group A, C polysaccharide meningitis in infants aged 3-5 months 4 weeks (28±3 days) after the infant series (three doses, 28 day apart)

  5. GMT of antibody against type b haemophilus Influenza in serum in infants aged 3-5 months

    Time frame: 4 weeks (28±3 days) after the infant series

    GMT of antibody against type b haemophilus Influenza in infants aged 3-5 months 4 weeks (28±3 days) after the infant series (three doses, 28 day apart)

Sponsors and collaborators

Lead sponsor

Jiangsu Province Centers for Disease Control and Prevention

Network

Collaborators

  • Royal (Wuxi) Biological Co., LTD

Registry information

Official study title

Immunogenicity and Safety Study of A Group A, C Polysaccharide Meningococcal and Type b Haemophilus Influenzal Conjugate Vaccine in Aged 3-5 Months: A Phase 3 Clinical Trial

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 18, 2012
Registry last updated
May 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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