Virus DiseasePhase 3NCT01183611
The Safety and Immunogenicity of Recombinant Hepatitis B Vaccines in the Health Neonates
A Phase 3 study testing Experimental recombinant hepatitis B vaccine, HBIG, Active Comparator hepatitis B vaccine and Experimental recombinant hepatitis B vaccine in people with Virus Disease and DNA Virus Infections, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
Trial summary
The primary safety objective of this study is to assess the safety of 10 mcg recombinant hepatitis B vaccine in the Chinese health neonates. The primary immunogenicity objective is to assess the antibody response following 3 doses immunization of the 10 mcg experimental dose and 10 or 5 mcg control dose, Participants… Read more about this study
- Who is it for?
- Ages Up to 24 hours
- Conditions the study is for
- Virus Disease, DNA Virus Infections, Hepadnaviridae Infections
- What is being tested?
- Experimental recombinant hepatitis B vaccine, HBIG, Active Comparator hepatitis B vaccine and Experimental recombinant hepatitis B vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,740 participants
- Where
- 1 siteChina
- Study dates
- Apr 2007to Sep 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- A group (A1-A2)Subjects born to a mother positive for both HBsAg and hepatitis B e antigen.
- Healthy male and female full-term (37-42 weeks gestation) neonates (birth to 1 day of age)
- Subjects with a 5-minute Apgar score ≥ 7.
- Subjects with temperature <37.1°C on axillary setting
- Subjects with a birth weight ≥ 2.5 kg.
- Normal neonatal jaundice.
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- Written informed consent obtained from the parent(s) of the subject.
- Subjects who the investigator believes that their parent(s) can and will comply with the requirements of the protocol.
- B group(B1-B2) Subjects born to a mother positive for HBsAg, but negative for the hepatitis B e antigen.
- Healthy male and female full-term (37-42 weeks gestation) neonates (birth to 1 day of age)
- Subjects with a 5-minute Apgar score ≥ 7.
- Subjects with temperature <37.1°C on axillary setting
- Subjects with a birth weight ≥2.5 kg.
- Normal neonatal jaundice.
- Written informed consent obtained from the parent(s) of the subject.
- Subjects who the investigator believes that their parent(s) can and will comply with the requirements of the protocol
- C group（C1-C3）Subjects born to a mother negative for HBsAg, hepatitis Be Antigen, antibody to hepatitis B core antigen, antibody to hepatitis B e-antigen.
- Healthy male and female full-term (37-42 weeks gestation) neonates (birth to 1 day of age)
- Subjects with a 5-minute Apgar score ≥ 7.
- Subjects with temperature <37.1°C on axillary setting
- Subjects with a birth weight ≥ 2.5 kg.
- Normal neonatal jaundice.
- Written informed consent obtained from the parent(s) of the subject.
- Subjects who the investigator believes that their parent(s) can and will comply with the requirements of the protocol.
Who cannot join
- A group (A1-A2) Subjects born to a mother positive for both HBsAg and e Antigen.
- Exclusion criteria for the first shot • Subjects born to a mother positive for antibody to HBsAg. • Family history of seizures or progressive neurological disease. • Family history of congenital or hereditary immunodeficiency. • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Subjects born to a mother had administrated of immunoglobulins and/or any blood products during the pregnancy.
- Use of any investigational or non-registered product other than the study vaccines since birth, or planned use during the study period.
- Born to a mother known or suspected to be positive for HIV.
Show all 55Show fewer
- Family history of congenital or hereditary immunodeficiency.
- Children in care.
- Neonatal jaundice requiring systemic treatment.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Major congenital defects or serious chronic illness, including perinatal brain damage.
- Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives Exclusion criteria for the second and third shots
- Dysgenopathy
- Any reaction or hypersensitivity to the hepatitis B vaccines.
- Acute infections
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
- <!-- -->
- B group (B1-B2) Subjects born to a mother positive for HBsAg, but negative for the hepatitis B e antigen.
- Exclusion criteria for the first shot • Subjects born to a mother positive for antibody to HBsAg or e antigen. • Family history of seizures or progressive neurological disease. • Family history of congenital or hereditary immunodeficiency.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Subjects born to a mother had administrated of immunoglobulins and/or any blood products during the pregnancy.
- Use of any investigational or non-registered product other than the study vaccines since birth, or planned use during the study period.
- Born to a mother known or suspected to be positive for HIV.
- Family history of congenital or hereditary immunodeficiency.
- Children in care.
- Neonatal jaundice requiring systemic treatment.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Major congenital defects or serious chronic illness, including perinatal brain damage.
- Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives Exclusion criteria for the second and third shots
- Dysgenopathy
- Any reaction or hypersensitivity to the hepatitis B vaccines.
- Acute infections
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- 3 C group (C1-C3) Subjects born to a mother negative for HBsAg, hepatitis Be Antigen, antibody to hepatitis B core antigen, antibody to hepatitis B e-antigen.
- Subjects born to a mother positive for antibody to HBsAg, or e antigen, or antibody to B core antigen or antibody to hepatitis B e-antigen.
- Family history of seizures or progressive neurological disease.
- Family history of congenital or hereditary immunodeficiency.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Subjects born to a mother had administrated of immunoglobulins and/or any blood products during the pregnancy.
- Use of any investigational or non-registered product other than the study vaccines since birth, or planned use during the study period.
- Born to a mother known or suspected to be positive for HIV.
- Family history of congenital or hereditary immunodeficiency.
- Children in care.
- Neonatal jaundice requiring systemic treatment.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Major congenital defects or serious chronic illness, including perinatal brain damage.
- Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives Exclusion criteria for the second and third shots
- Dysgenopathy
- Any reaction or hypersensitivity to the hepatitis B vaccines.
- Acute infections
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, 210009
About this study
Official title: The Safety and Immunogenicity of Recombinant Hepatitis B Vaccines in the Health Neonates Born to Mother With Positive for Both HBsAg and HBeAg, Positive for HBsAg But Negative for HBeAg, Negative for HBsAg, HBeAg, HBeAb and HBcAb
The primary safety objective of this study is to assess the safety of 10 mcg recombinant hepatitis B vaccine in the Chinese health neonates. The primary immunogenicity objective is to assess the antibody response following 3 doses immunization of the 10 mcg experimental dose and 10 or 5 mcg control dose, Participants will include up to 1740 healthy neonates. This is a randomized, double-blinded, Phase III study. This study is designed to investigate the safety, reactogenicity, and immunogenicity of 10ug recombinant hepatitis B vaccine (yeast). Subjects will be stratified by the mother with positive for both HBsAg and HBeAg, positive for the surface antigen but negative for HBeAg, negative for the HBsAg and HBeAg and HBeAb and HBcAb.
- Stratified 1: There are 180 neonates born to the mother with positive for both HBsAg and HBeAg will be randomized into two groups according to the ratio of 2:1. 120 subjects will receive the 10 mcg experimental vaccine and 60 subjects will receive 10 mcg control vaccine respectively.
- Stratified 2: There are 360 neonates born to the mother with positive for HBsAg but negative for HBeAg will be randomized into two groups according to the ratio of 2:1. 240 subjects will receive the 10 mcg experimental vaccine and 120 subjects will receive 10 mcg control vaccine respectively.
- Stratified 3: There are 1200 neonates born to the mother with negative for the HBsAg and HBeAg and HBeAb and HBcAb will be randomized into 3 groups. 600 of them will receive the 10mcg experimental vaccine. 300 subjects will receive 10mcg control vaccine. And the other 300 subjects will receive 5mcg control vaccine.
The recombinant hepatitis B vaccine will be administered at m0, 1 and 6. Following each immunization, safety will be measured by assessment of adverse events through 30 days following each vaccination, serious adverse events and new-onset chronic medical conditions through 6 months post the final vaccination (Day 180 after last vaccination). For the immunogenicity testing will apply the chemiluminescence immunoassay on serum obtained on the day 0, 210 and 360 after born.
Read the detailed description
During the early 1980s, human plasma-derived hepatitis B vaccines were developed in China. The production of these vaccines has not been adequate to meet China's need. Since the introduction of recombinant vaccines which can be produced in large quantity, at low cost, the emphasis has been placed on a search for a recombinant hepatitis B vaccine. This vaccine is thought to be safe, immunogenic, particularly in infants born to carrier mothers. Since 1992, the 5mcg recombinant hepatitis B vaccine has been used as one of the vaccines in the expanded immunization programs (People's Republic of China). The 5ug recombinant hepatitis B vaccine (yeast) is efficacious in short time but not to persistent in neonates. The primary safety objective of this study is to assess the safety of 10 mcg recombinant hepatitis B vaccine in the chinese health neonates. The primary immunogenicity objective is to assess the antibody response following 3 doses immunization of the 10 mcg experimental dose and 10, 5 mcg control dose, Participants will include up to 1740 healthy neonates.
The primary safety objective of this study is to assess the safety of 10 mcg recombinant hepatitis B vaccine in the Chinese health neonates. The primary immunogenicity objective is to assess the antibody response following 3 doses immunization of the 10 mcg experimental dose and 10 or 5 mcg control dose, Participants will include up to 1740 healthy neonates. This is a randomized, double-blinded, Phase III study. This study is designed to investigate the safety, reactogenicity, and immunogenicity of 10ug recombinant hepatitis B vaccine (yeast). Subjects will be stratified by the mother with positive for both HBsAg and HBeAg, positive for the surface antigen but negative for HBeAg, negative for the HBsAg and HBeAg and HBeAb and HBcAb.
- Stratified 1: There are 180 neonates born to the mother with positive for both HBsAg and HBeAg will be randomized into two groups according to the ratio of 2:1. 120 subjects will receive the 10 mcg experimental vaccine and 60 subjects will receive 10 mcg control vaccine respectively.
- Stratified 2: There are 360 neonates born to the mother with positive for HBsAg but negative for HBeAg will be randomized into two groups according to the ratio of 2:1. 240 subjects will receive the 10 mcg experimental vaccine and 120 subjects will receive 10 mcg control vaccine respectively.
- Stratified 3: There are 1200 neonates born to the mother with negative for the HBsAg and HBeAg and HBeAb and HBcAb will be randomized into 3 groups. 600 of them will receive the 10mcg experimental vaccine. 300 subjects will receive 10mcg control vaccine. And the other 300 subjects will receive 5mcg control vaccine.
All these neonates will have the vaccination within 24 hours after born. The recombinant hepatitis B vaccine will be administered at m0, 1 and 6. Following each immunization, safety will be measured by assessment of adverse events through 30 days following each vaccination, serious adverse events and new-onset chronic medical conditions through 6 months post the final vaccination (Day 180 after last vaccination). For the immunogenicity testing will apply the chemiluminescence immunoassay on serum obtained on the day 0, 210 and 360 after born.
- Being tested
- Experimental recombinant hepatitis B vaccine, HBIG, Active Comparator hepatitis B vaccine, Experimental recombinant hepatitis B vaccine, Active Comparator recombinant hepatitis B vaccine., Placebo Comparator recombinant hepatitis B vaccine
- Keywords
- safety, immunogenicity, HBV vaccine, perinatal transmission
- Medical subject headings
- Virus Diseases, DNA Virus Infections, Hepadnaviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental recombinant hepatitis B vaccine, HBIGBiological
Experimental 10mcg/0.5 ml recombinant hepatitis B vaccine and 200IU HBIG
Active Comparator hepatitis B vaccineBiological
Active Comparator 10mcg/0.5 ml of recombinant hepatitis B vaccine，200IU HBIG
Experimental recombinant hepatitis B vaccineBiological
Experimental 10mcg/0.5 ml of recombinant hepatitis B vaccine
Active Comparator recombinant hepatitis B vaccine.Biological
Active Comparator 10mcg/0.5 ml of recombinant hepatitis B vaccine.
Placebo Comparator recombinant hepatitis B vaccineBiological
Placebo Comparator 10mcg/0.5 ml of recombinant hepatitis B vaccine.
| Study group | Role | What they receive |
|---|---|---|
| A1 | Experimental | health neonates born to mother with positive for both HBsAg and e antigen Receives: Biological: Experimental recombinant hepatitis B vaccine, HBIG |
| A2 | Active comparator | health neonates born to mother with positive for both HBsAg and e antigen Receives: Biological: Active Comparator hepatitis B vaccine |
| B1 | Experimental | health neonates born to a mother positive for HBsAg, negative for the hepatitis B e antigen Receives: Biological: Experimental recombinant hepatitis B vaccine, HBIG |
| B2 | Active comparator | health neonates born to a mother positive for HBsAg, negative for the hepatitis B e antigen Receives: Biological: Active Comparator hepatitis B vaccine |
| C1 | Experimental | health neonates born to mother with negative for the HBsAg and HBeAg and HBeAb and HBcAb Receives: Biological: Experimental recombinant hepatitis B vaccine |
| C2 | Active comparator | health neonates born to mother with negative for the HBsAg and HBeAg and HBeAb and HBcAb Receives: Biological: Active Comparator recombinant hepatitis B vaccine. |
| C3 | Placebo comparator | health neonates born to mother with negative for the HBsAg and HBeAg and HBeAb and HBcAb Receives: Biological: Placebo Comparator recombinant hepatitis B vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The immunogenicity of experimental recombinant HBV vaccines in healthy neonates on day 210
Immunogenicity testing will be chemiluminescence immunoassay on serum obtained on day 210 after first dose
Measured: on day 210 after the first dose
The immunogenicity of experimental recombinant HBV vaccines in healthy neonates on day 360
Immunogenicity testing will be chemiluminescence immunoassay on serum obtained on day 360 after first dose
Measured: on day 360 after the first dose
Secondary outcomes (3)
To evaluate the safety of recombinant HBV vaccines in the health neonates after first dose
assessment of adverse events through 30 days following first dose
Measured: within the first 30 days after first dose
To evaluate the safety of recombinant HBV vaccines in the health neonates after second dose
assessment of adverse events through 30 days following second dose
Measured: within the first 30 days after second dose
To evaluate the safety of recombinant HBV vaccines in the health neonates after third dose
assessment of adverse events through 30 days following third dose
Measured: within the first 30 days after third dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study startApr 2007
- Primary completionJun 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Virus DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,740 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Sponsor type
- Research network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01183611
- Sponsor's protocol ID
- JSVCT008
- Status last verified
- Sep 2010
- First submitted
- 10 May 2010
- Last updated
- 17 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhu FC, Liang ZL, Meng FY, Zeng Y, Mao QY, Chu K, Song XF, Yao X, Li JX, Ji H, Zhang YJ, Li L, Pan HX, Xu K, Dai WM, Zhang WW, Deng F, Wang H, Wang JZ. Retrospective study of the incidence of HFMD and seroepidemiology of antibodies against EV71 and CoxA16 in prenatal women and their infants. PLoS One. 2012;7(5):e37206. doi: 10.1371/journal.pone.0037206. Epub 2012 May 25.
PubMed 22662137
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Immunogenicity of Recombinant Hepatitis B Vaccines in the Health Neonates Born to Mother With Positive for Both HBsAg and HBeAg, Positive for HBsAg But Negative for HBeAg, Negative for HBsAg, HBeAg, HBeAb and HBcAb
- ClinicalTrials.gov ID
- NCT01183611
- Acronym / sponsor ID
- JSVCT008
- Keywords
- safety, immunogenicity, HBV vaccine, perinatal transmission
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,740 participants (estimated)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Study start
- Apr 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 17 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary safety objective of this study is to assess the safety of 10 mcg recombinant hepatitis B vaccine in the Chinese health neonates. The primary immunogenicity objective is to assess the antibody response following 3 doses immunization of the 10 mcg experimental dose and 10 or 5 mcg control dose, Participants will include up to 1740 healthy neonates. This is a randomized, double-blinded, Phase III study. This study is designed to investigate the safety, reactogenicity, and immunogenicity of 10ug recombinant hepatitis B vaccine (yeast). Subjects will be stratified by the mother with positive for both HBsAg and HBeAg, positive for the surface antigen but negative for HBeAg, negative for the HBsAg and HBeAg and HBeAb and HBcAb.
- Stratified 1: There are 180 neonates born to the mother with positive for both HBsAg and HBeAg will be randomized into two groups according to the ratio of 2:1. 120 subjects will receive the 10 mcg experimental vaccine and 60 subjects will receive 10 mcg control vaccine respectively.
- Stratified 2: There are 360 neonates born to the mother with positive for HBsAg but negative for HBeAg will be randomized into two groups according to the ratio of 2:1. 240 subjects will receive the 10 mcg experimental vaccine and 120 subjects will receive 10 mcg control vaccine respectively.
- Stratified 3: There are 1200 neonates born to the mother with negative for the HBsAg and HBeAg and HBeAb and HBcAb will be randomized into 3 groups. 600 of them will receive the 10mcg experimental vaccine. 300 subjects will receive 10mcg control vaccine. And the other 300 subjects will receive 5mcg control vaccine.
The recombinant hepatitis B vaccine will be administered at m0, 1 and 6. Following each immunization, safety will be measured by assessment of adverse events through 30 days following each vaccination, serious adverse events and new-onset chronic medical conditions through 6 months post the final vaccination (Day 180 after last vaccination). For the immunogenicity testing will apply the chemiluminescence immunoassay on serum obtained on the day 0, 210 and 360 after born.
Detailed description
During the early 1980s, human plasma-derived hepatitis B vaccines were developed in China. The production of these vaccines has not been adequate to meet China's need. Since the introduction of recombinant vaccines which can be produced in large quantity, at low cost, the emphasis has been placed on a search for a recombinant hepatitis B vaccine. This vaccine is thought to be safe, immunogenic, particularly in infants born to carrier mothers. Since 1992, the 5mcg recombinant hepatitis B vaccine has been used as one of the vaccines in the expanded immunization programs (People's Republic of China). The 5ug recombinant hepatitis B vaccine (yeast) is efficacious in short time but not to persistent in neonates. The primary safety objective of this study is to assess the safety of 10 mcg recombinant hepatitis B vaccine in the chinese health neonates. The primary immunogenicity objective is to assess the antibody response following 3 doses immunization of the 10 mcg experimental dose and 10, 5 mcg control dose, Participants will include up to 1740 healthy neonates.
The primary safety objective of this study is to assess the safety of 10 mcg recombinant hepatitis B vaccine in the Chinese health neonates. The primary immunogenicity objective is to assess the antibody response following 3 doses immunization of the 10 mcg experimental dose and 10 or 5 mcg control dose, Participants will include up to 1740 healthy neonates. This is a randomized, double-blinded, Phase III study. This study is designed to investigate the safety, reactogenicity, and immunogenicity of 10ug recombinant hepatitis B vaccine (yeast). Subjects will be stratified by the mother with positive for both HBsAg and HBeAg, positive for the surface antigen but negative for HBeAg, negative for the HBsAg and HBeAg and HBeAb and HBcAb.
- Stratified 1: There are 180 neonates born to the mother with positive for both HBsAg and HBeAg will be randomized into two groups according to the ratio of 2:1. 120 subjects will receive the 10 mcg experimental vaccine and 60 subjects will receive 10 mcg control vaccine respectively.
- Stratified 2: There are 360 neonates born to the mother with positive for HBsAg but negative for HBeAg will be randomized into two groups according to the ratio of 2:1. 240 subjects will receive the 10 mcg experimental vaccine and 120 subjects will receive 10 mcg control vaccine respectively.
- Stratified 3: There are 1200 neonates born to the mother with negative for the HBsAg and HBeAg and HBeAb and HBcAb will be randomized into 3 groups. 600 of them will receive the 10mcg experimental vaccine. 300 subjects will receive 10mcg control vaccine. And the other 300 subjects will receive 5mcg control vaccine.
All these neonates will have the vaccination within 24 hours after born. The recombinant hepatitis B vaccine will be administered at m0, 1 and 6. Following each immunization, safety will be measured by assessment of adverse events through 30 days following each vaccination, serious adverse events and new-onset chronic medical conditions through 6 months post the final vaccination (Day 180 after last vaccination). For the immunogenicity testing will apply the chemiluminescence immunoassay on serum obtained on the day 0, 210 and 360 after born.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| A1 | Experimental | Biological: Experimental recombinant hepatitis B vaccine, HBIGhealth neonates born to mother with positive for both HBsAg and e antigen |
| A2 | Active comparator | Biological: Active Comparator hepatitis B vaccinehealth neonates born to mother with positive for both HBsAg and e antigen |
| B1 | Experimental | Biological: Experimental recombinant hepatitis B vaccine, HBIGhealth neonates born to a mother positive for HBsAg, negative for the hepatitis B e antigen |
| B2 | Active comparator | Biological: Active Comparator hepatitis B vaccinehealth neonates born to a mother positive for HBsAg, negative for the hepatitis B e antigen |
| C1 | Experimental | Biological: Experimental recombinant hepatitis B vaccinehealth neonates born to mother with negative for the HBsAg and HBeAg and HBeAb and HBcAb |
| C2 | Active comparator | Biological: Active Comparator recombinant hepatitis B vaccine.health neonates born to mother with negative for the HBsAg and HBeAg and HBeAb and HBcAb |
| C3 | Placebo comparator | Biological: Placebo Comparator recombinant hepatitis B vaccinehealth neonates born to mother with negative for the HBsAg and HBeAg and HBeAb and HBcAb |
Who may qualify
- Ages
- Up to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (24 listed)
- A group (A1-A2)Subjects born to a mother positive for both HBsAg and hepatitis B e antigen.
- B group(B1-B2) Subjects born to a mother positive for HBsAg, but negative for the hepatitis B e antigen.
- C group（C1-C3）Subjects born to a mother negative for HBsAg, hepatitis Be Antigen, antibody to hepatitis B core antigen, antibody to hepatitis B e-antigen.
Key exclusion criteria (55 listed)
- A group (A1-A2) Subjects born to a mother positive for both HBsAg and e Antigen.
- Exclusion criteria for the first shot • Subjects born to a mother positive for antibody to HBsAg. • Family history of seizures or progressive neurological disease. • Family history of congenital or hereditary immunodeficiency. • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- <!-- -->
- B group (B1-B2) Subjects born to a mother positive for HBsAg, but negative for the hepatitis B e antigen.
- Exclusion criteria for the first shot • Subjects born to a mother positive for antibody to HBsAg or e antigen. • Family history of seizures or progressive neurological disease. • Family history of congenital or hereditary immunodeficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental recombinant hepatitis B vaccine, HBIGExperimental 10mcg/0.5 ml recombinant hepatitis B vaccine and 200IU HBIG | Biological | A1, B1 |
| Active Comparator hepatitis B vaccineActive Comparator 10mcg/0.5 ml of recombinant hepatitis B vaccine，200IU HBIG | Biological | A2, B2 |
| Experimental recombinant hepatitis B vaccineExperimental 10mcg/0.5 ml of recombinant hepatitis B vaccine | Biological | C1 |
| Active Comparator recombinant hepatitis B vaccine.Active Comparator 10mcg/0.5 ml of recombinant hepatitis B vaccine. | Biological | C2 |
| Placebo Comparator recombinant hepatitis B vaccinePlacebo Comparator 10mcg/0.5 ml of recombinant hepatitis B vaccine. | Biological | C3 |
Primary outcome
The immunogenicity of experimental recombinant HBV vaccines in healthy neonates on day 210
Time frame: on day 210 after the first dose
Immunogenicity testing will be chemiluminescence immunoassay on serum obtained on day 210 after first dose
The immunogenicity of experimental recombinant HBV vaccines in healthy neonates on day 360
Time frame: on day 360 after the first dose
Immunogenicity testing will be chemiluminescence immunoassay on serum obtained on day 360 after first dose
3 secondary outcomes
To evaluate the safety of recombinant HBV vaccines in the health neonates after first dose
Time frame: within the first 30 days after first dose
To evaluate the safety of recombinant HBV vaccines in the health neonates after second dose
Time frame: within the first 30 days after second dose
To evaluate the safety of recombinant HBV vaccines in the health neonates after third dose
Time frame: within the first 30 days after third dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2010.
- Derived from this study: PubMed 22662137Zhu FC, Liang ZL, Meng FY, Zeng Y, Mao QY, Chu K, Song XF, Yao X, Li JX, Ji H, Zhang YJ, Li L, Pan HX, Xu K, Dai WM, Zhang WW, Deng F, Wang H, Wang JZ. Retrospective study of the incidence of HFMD and seroepidemiology of antibodies against EV71 and CoxA16 in prenatal women and their infants. PLoS One. 2012;7(5):e37206. doi: 10.1371/journal.pone.0037206. Epub 2012 May 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Experimental recombinant hepatitis B vaccine, HBIG, Active Comparator hepatitis B vaccine and Experimental recombinant hepatitis B vaccine in people with Virus Disease and DNA Virus Infections, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 55 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The immunogenicity of experimental recombinant HBV vaccines in healthy neonates on day 210 (time frame: on day 210 after the first dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01183611, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2010.