Streptococcal PneumoniaNCT02133469
PCV7 in the Prevention of Nasopharyngeal Carriage of Vaccine Serotype (VT) Streptococcus Pneumoniae
A study testing PCV7 (Pneumococcal 7-Valent Conjugate Vaccine) and Hib Vaccine in people with Streptococcal Pneumonia and Nasopharyngeal Diseases, run by Centers for Disease Control and Prevention, China at 9 sites in China.
Trial summary
A parallel-group, randomized, open-label study will be performed in subjects receiving PCV7 and subjects receiving controlled vaccine Hib vaccine, to claim the efficacy of PCV7 in the prevention of NP carriage of vaccine-serotype S. Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Streptococcal Pneumonia, Nasopharyngeal Diseases, Vaccination Adverse Event
- What is being tested?
- PCV7 (Pneumococcal 7-Valent Conjugate Vaccine) and Hib Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,281 participants
- Where
- 9 sitesChina
- Study dates
- Jun 2012to May 2014
- Phase
- Interventional
- 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 2 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children aged 2 to 5 years.
- Evidence of a personally signed and dated informed consent document indicating that the parent(s) (or legal guardian) has been informed of all pertinent aspects of the study.
- Subjects and parents / legal guardian/ adult caregiver who are willing and able to comply with scheduled visits, treatment plan, and other study procedures.
- Available for entire study period and whose parent/legal guardian/adult caregiver can be reached by telephone.
- Healthy child as determined by medical history, physical examination, and judgment of the investigator.
Who cannot join
- Previous vaccination with licensed or investigational pneumococcal vaccine.
- Receipt of a full series or catch-up dose of licensed or investigational Hib vaccinations.
- Contraindication to vaccination with a pneumococcal conjugate vaccine or Hib.
- Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
- Known or suspected immune deficiency or suppression including treatment with systemic steroids, anti-metabolites, chemotherapy and immunomodulatory agents.
- Major known congenital malformation or serious chronic disorder.
Show all 14Show fewer
- Malformation or injury of the nasopharynx that makes the procedure of taking a nasopharyngeal swab impossible.
- Significant neurologic disorder including congenital neurological disease in sibling of the subject or history of seizure including febrile seizure, or significant stable or evolving disorder such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorder. Does not include resolving syndromes due to birth trauma such as Erb's palsy.
- Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies) within 12 weeks prior to enrollment.
- Participation in another investigational or interventional trial within the 28-day period before enrollment and during the conduct of the study. Participation in purely observational studies is acceptable.
- Subjects whose parents or legal representative are investigational site staff members or subjects whose parents or legal representative are Pfizer employees directly involved in the conduct of the trial.
- Temporary Exclusion Criteria(The following conditions are temporary or self-limiting and a subject may be included in the study once the condition(s) has/have resolved and no other exclusion criteria are met):
- Subjects with current febrile illness (axillary temperature of ≥ 38.0ºC).
- Subjects who used antibiotics within the previous 15 days.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Huairou District Center for Disease Prevention and Control
Beijing, Beijing Municipality, 101400
Daxing District Center for Disease Prevention and Control
Beijing, Beijing Municipality, 102600
Chongwen District Center for Disease Control and Prevention
Beijing, Beijing Municipality
Shijingshan District Center for Disease Control and Prevention
Beijing, Beijing Municipality
Xuanwu District Center for Disease Control and Prevention
Beijing, Beijing Municipality
Chaoyang District Center for Disease Control and Prevention
Chaoyang District, Beijing Municipality
Dongcheng District Center for Disease Control and Prevention
Dongcheng District, Beijing Municipality
Fengtai District Center for Disease Control and Prevention
Fengtai District, Beijing Municipality
Xicheng District Center for Disease Prevention and Control
Xicheng District, Beijing Municipality, 100120
About this study
Official title: Effectiveness of PCV7 in the Prevention of Nasopharyngeal Carriage of Vaccine Serotype (VT) Streptococcus Pneumoniae in 2 to 5 Years Old Healthy Chinese Children.
A parallel-group, randomized, open-label study will be performed in subjects receiving PCV7 and subjects receiving controlled vaccine Hib vaccine, to claim the efficacy of PCV7 in the prevention of NP carriage of vaccine-serotype S. pneumoniae (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F combined) in 2 to 5 years old healthy Chinese children.
Read the detailed description
In 2005, clinical trials with PCV7 (Prevenar) were first conducted in China. In the phase 3 study involving Chinese infants, Prevenar was shown to be immunogenic, well tolerated, and safe when given either separately or concomitantly with a diphtheria, tetanus, and acellular pertussis (DTaP) vaccine at 3, 4, and 5 months of age. Controlled clinical trials elsewhere in the world showed the correlation between immunogenicity and disease prevention. In addition to the direct effect of Prevenar, immunization of children has also reduced the incidence of disease in adults. The changes are presumed to be due to reductions in nasopharyngeal carriage of vaccine serotype S. pneumoniae in children who have been vaccinated.
The purpose of this study will be to assess the effectiveness of Prevenar vaccination to reduce vaccine serotype (VT) NPC rates in Chinese children aged 2 to 5 years old.
- Being tested
- PCV7 (Pneumococcal 7-Valent Conjugate Vaccine), Hib Vaccine
- Keywords
- Effectiveness, Prevenar, nasopharyngeal carriage, vaccine serotype
- Medical subject headings
- Pneumonia, Nasopharyngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCV7 (Pneumococcal 7-Valent Conjugate Vaccine)Biological
Also called Prevenar
injection 0.5 mL, single dose
Hib VaccineBiological
Single Dose
| Study group | Role | What they receive |
|---|---|---|
| PCV7 (Vaccine) | Experimental | Randomized group of 1634 subjects to be administered a single dose of PCV7 (Hib vaccine offered at end of study). Receives: Biological: PCV7 (Pneumococcal 7-Valent Conjugate Vaccine) |
| Hib vaccine | Active comparator | Randomized group of 1634 subjects to be administered a single dose of Hib Vaccine(PCV7 vaccine offered at end of study). Receives: Biological: Hib Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carriage Rate of Vaccine-Serotype S. pneumoniae at 180days after vaccination
Measured: 6 months
Secondary outcomes (10)
Carriage Rate of vaccine-serotype S. pneumoniae in PCV7 group versus Hib group.
Measured: 60 days
Carriage rate of non-vaccine serotype S. pneumoniae in PCV7 group versus Hib group.
Measured: Baseline before vaccination
Carriage rate of non-vaccine serotype S. pneumoniae in PCV7 group versus Hib group.
Measured: 60 days after vaccination
Carriage rate of non-vaccine serotype S. pneumoniae in PCV7 group versus Hib group.
Measured: 6 months after vaccination
Carriage rate of individual serotype S. pneumoniae in PCV7 group and Hib group.
Measured: Baseline before vaccination
Carriage rate of individual serotype S. pneumoniae in PCV7 group and Hib group.
Measured: 60 days after vaccination
Carriage rates of individual serotype S. pneumoniae in PCV7 group and Hib group.
Measured: 6 months after vaccination
Carriage rate of antibiotic resistant S. pneumoniae as a group in PCV7 group and Hib group.
Measured: 6 months after vaccination
Percentage of adverse event related to vaccination in PVC7 group and Hib group.
Measured: 6 months after vaccination
Category of adverse event related to vaccination in PVC7 group and Hib group.
Adverse effects are classified as referenced from the China Food and Drug Administration's "Preventive Vaccines Clinical Study Adverse Effects Assessment Standards". This evaluation of systemic reactions is partially based on standards for classification set by the United States National Institutes of Health and the National Institute of Allergy and Infectious Diseases.
Measured: 6 months after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2014 (estimated)
- Study startJun 2012
- Primary completionApr 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Streptococcal PneumoniaStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,281 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention, China
- Sponsor type
- Other government
- Collaborators
- Beijing Municipal Health Bureau, Beijing Center for Disease Control and Prevention
- Responsible party
- Principal investigator, Wu Jiang, Centers for Disease Control and Prevention, China
- Investigators
- Wu Jiang, Bachelor, Principal investigator, Beijing Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02133469
- Sponsor's protocol ID
- BJCDCWJ201201
- Status last verified
- May 2014
- First submitted
- 7 May 2014
- Last updated
- 20 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of PCV7 in the Prevention of Nasopharyngeal Carriage of Vaccine Serotype (VT) Streptococcus Pneumoniae in 2 to 5 Years Old Healthy Chinese Children.
- ClinicalTrials.gov ID
- NCT02133469
- Acronym / sponsor ID
- BJCDCWJ201201
- Keywords
- Effectiveness, Prevenar, nasopharyngeal carriage, vaccine serotype
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,281 participants (actual)
- Lead sponsor
- Centers for Disease Control and Prevention, ChinaOther government
- Collaborators
- Beijing Municipal Health Bureau, Beijing Center for Disease Control and Prevention
- Study start
- Jun 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 8 May 2014 (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.
A parallel-group, randomized, open-label study will be performed in subjects receiving PCV7 and subjects receiving controlled vaccine Hib vaccine, to claim the efficacy of PCV7 in the prevention of NP carriage of vaccine-serotype S. pneumoniae (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F combined) in 2 to 5 years old healthy Chinese children.
Detailed description
In 2005, clinical trials with PCV7 (Prevenar) were first conducted in China. In the phase 3 study involving Chinese infants, Prevenar was shown to be immunogenic, well tolerated, and safe when given either separately or concomitantly with a diphtheria, tetanus, and acellular pertussis (DTaP) vaccine at 3, 4, and 5 months of age. Controlled clinical trials elsewhere in the world showed the correlation between immunogenicity and disease prevention. In addition to the direct effect of Prevenar, immunization of children has also reduced the incidence of disease in adults. The changes are presumed to be due to reductions in nasopharyngeal carriage of vaccine serotype S. pneumoniae in children who have been vaccinated.
The purpose of this study will be to assess the effectiveness of Prevenar vaccination to reduce vaccine serotype (VT) NPC rates in Chinese children aged 2 to 5 years old.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCV7 (Vaccine) | Experimental | Biological: PCV7 (Pneumococcal 7-Valent Conjugate Vaccine)Randomized group of 1634 subjects to be administered a single dose of PCV7 (Hib vaccine offered at end of study). |
| Hib vaccine | Active comparator | Biological: Hib VaccineRandomized group of 1634 subjects to be administered a single dose of Hib Vaccine(PCV7 vaccine offered at end of study). |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy children aged 2 to 5 years.
- Evidence of a personally signed and dated informed consent document indicating that the parent(s) (or legal guardian) has been informed of all pertinent aspects of the study.
- Subjects and parents / legal guardian/ adult caregiver who are willing and able to comply with scheduled visits, treatment plan, and other study procedures.
- Available for entire study period and whose parent/legal guardian/adult caregiver can be reached by telephone.
- Healthy child as determined by medical history, physical examination, and judgment of the investigator.
Key exclusion criteria (14 listed)
- Previous vaccination with licensed or investigational pneumococcal vaccine.
- Receipt of a full series or catch-up dose of licensed or investigational Hib vaccinations.
- Contraindication to vaccination with a pneumococcal conjugate vaccine or Hib.
- Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
- Known or suspected immune deficiency or suppression including treatment with systemic steroids, anti-metabolites, chemotherapy and immunomodulatory agents.
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 |
|---|---|---|
| PCV7 (Pneumococcal 7-Valent Conjugate Vaccine)Also: Prevenarinjection 0.5 mL, single dose | Biological | PCV7 (Vaccine) |
| Hib VaccineSingle Dose | Biological | Hib vaccine |
Primary outcome
Carriage Rate of Vaccine-Serotype S. pneumoniae at 180days after vaccination
Time frame: 6 months
10 secondary outcomes
Carriage Rate of vaccine-serotype S. pneumoniae in PCV7 group versus Hib group.
Time frame: 60 days
Carriage rate of non-vaccine serotype S. pneumoniae in PCV7 group versus Hib group.
Time frame: Baseline before vaccination
Carriage rate of non-vaccine serotype S. pneumoniae in PCV7 group versus Hib group.
Time frame: 60 days after vaccination
Carriage rate of non-vaccine serotype S. pneumoniae in PCV7 group versus Hib group.
Time frame: 6 months after vaccination
Carriage rate of individual serotype S. pneumoniae in PCV7 group and Hib group.
Time frame: Baseline before vaccination
Carriage rate of individual serotype S. pneumoniae in PCV7 group and Hib group.
Time frame: 60 days after vaccination
Carriage rates of individual serotype S. pneumoniae in PCV7 group and Hib group.
Time frame: 6 months after vaccination
Carriage rate of antibiotic resistant S. pneumoniae as a group in PCV7 group and Hib group.
Time frame: 6 months after vaccination
Percentage of adverse event related to vaccination in PVC7 group and Hib group.
Time frame: 6 months after vaccination
Category of adverse event related to vaccination in PVC7 group and Hib group.
Time frame: 6 months after vaccination
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 20 May 2016.
Related trials for Streptococcal Pneumonia
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
RecruitingPhase 4
Opportunistic Pneumococcal Immunisation Trial in MALnutrition
Severe Acute Malnutrition in Childhood, Pneumococcal Disease
RecruitingObservational study
Urine Pneumococcal Antigen Project
Pneumonia, Pneumonia - Bacterial
Active, not recruitingPhase 2/3
A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women
Streptococcus Agalactiae Infection, Neonatal Sepsis
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.
Wu Jiang, Bachelor principal investigator
Beijing Centers for Disease Control and Prevention
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCV7 (Pneumococcal 7-Valent Conjugate Vaccine) and Hib Vaccine in people with Streptococcal Pneumonia and Nasopharyngeal Diseases, run by Centers for Disease Control and Prevention, China at 9 sites 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 5 inclusion and 14 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 20 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Carriage Rate of Vaccine-Serotype S. pneumoniae at 180days after vaccination (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2016.