Pneumococcal InfectionsPhase 2NCT00170612
Pneumococcal Vaccination of Fiji Infants
A Phase 2 study testing Pneumovax 23 and Prevnar in people with Pneumococcal Infections, run by University of Melbourne at 1 site in Fiji.
Trial summary
Pneumonia is the most common reason for admission of Fijian children to hospitals. The most common germ causing pneumonia is "streptococcus pneumoniae." It is a common cause of meningitis (infection around the brain and spinal cord), ear infections, and blood infections and it lives in the nose of humans. Read more about this study
- Who is it for?
- Ages 6 to 8 weeksHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infections
- What is being tested?
- Pneumovax 23 and Prevnar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 552 participants
- Where
- 1 siteFiji
- Study dates
- Nov 2005to Aug 2008
- Phase
- Phase 2
- 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 6 to 8 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infant aged between 6 and 8 weeks
- No significant maternal or perinatal history
- Written and signed parental/caregiver consent
- Lives within 30 minutes of the health clinic
- Family anticipate living in the study area for the next 2 years
Who cannot join
- Known allergy to any component of the vaccine
- Allergic reaction or anaphylactoid reaction with previous vaccines
- Known immunodeficiency disorder
- HIV positive mother (many women are tested for HIV antenatally, however a test is not planned; therefore it would be based on clinic records or self report)
- Known thrombocytopenia or coagulation disorder
- On immunosuppressive medication
Show all 12Show fewer
- Received any blood product since birth
- Severe congenital anomaly
- Chronic or progressive disease
- Seizure disorder
- History of invasive Pneumococcal, meningococcal, or Haemophilus influenzae diseases
- Moderate or severe acute infection (temporary exclusion); Minor illnesses such as an uncomplicated upper respiratory tract infection, localized skin infections, or mild diarrhea will not be an exclusion criterion
Trial locations and contacts
1 site in 1 country.
Fiji1 site
Colonial War Memorial Hospital
Suva
About this study
Official title: A Single-Blind Open-Label Randomized Phase II Study of the Safety, Immunogenicity and Impact on Pneumococcus (Pnc) Carriage of the Pnc Vaccination Regimens Combining 1, 2, or 3 Doses of 7-Valent Pneumococcal Conjugate Vaccine (PCV) in the First 4 Months of Life Followed by a Single Dose of 23-Valent Pneumococcal Polysaccharide Vaccine (PPS) at 12 Months of Age
Pneumonia is the most common reason for admission of Fijian children to hospitals. The most common germ causing pneumonia is "streptococcus pneumoniae." It is a common cause of meningitis (infection around the brain and spinal cord), ear infections, and blood infections and it lives in the nose of humans. A vaccine has been developed that will help prevent these common diseases but prevents only about one quarter of pneumonia cases and it is expensive. This study explores new ways of giving this vaccine that are affordable, safe, and effective in countries such as Fiji. About 550 Fijian infants presenting at 6 weeks of age, for their first diptheria, tetanus, toxoid, pertussis vaccine immunization, to one of the participating Health Centers or Colonial War Memorial Hospital in urban Suva, Fiji will be enrolled. Children will remain in the study for 2 years. Study procedures include full vaccination against 7 types of pneumococcus, blood tests, and nasal swabs.
Read the detailed description
This research project began as a study of alternative strategies for Pnc (Pneumococcus) immunization for children in developing countries. In the original study, infants presenting to a health center in urban Fiji were randomized to receive 1, 2, or 3 doses of PCV (Prevnar) followed by a dose of 23-valent PPS (Pneumococcal polysaccharide vaccine) at 6 or 9 months of age. The regimens were compared with each other and with 2 control groups with respect to immunogenicity, impact on carriage of vaccine type Pnc, and response to a small dose of PPS at 15 months of age. After the trial was underway and 228 infants had been recruited, concerns were raised about the safety of PPS in infancy. Specifically concerns were raised that it might result in later immunological hyporesponsiveness in some of the recipients, to some of the serotypes. After a thorough review it was decided to proceed with the study, but to modify it so that it addressed directly the issue of potential hyporesponsiveness, while not giving PPS to any children under 12 months of age. This protocol represents the completion of the study with the new design for the children already enrolled, and a new design for a further cohort of children who will be enrolled. The newly designed trial will be a single blind, open-label, randomized, controlled trial of 550 healthy infants. Infants will be randomized to 1 of 8 equal groups to receive 0, 1, 2, or 3 doses of PCV (Pneumococcal conjugate vaccine), with or without a booster of PPS at 12 months of age. Two control groups will be recruited, 1 will receive no PCV in infancy and the other will receive a dose of PPS at 12 months of age. At 18 months of age, all infants will receive a 20 percent dose of PPS to stimulate and allow the assessment of immunological memory. At 2 years of age, any child who has received no or one dose of PCV (Groups E, F, G and H) will receive a single dose of PCV. Blood samples will be taken at 18 weeks age, 12 months of age, before the 18 months dose and 4 weeks later. In addition half of the children will have a blood sample taken at 9 months and the other half will have a sample taken 2 weeks after their 12 month dose of PPS. The 9- and 12-month blood sample will assess the long-term persistence of circulating antibody and avidity maturation following a 1, 2, or 3 dose primary series of PCV. The primary objective is to demonstrate noninferiority at 19 months of age, of those groups receiving PPS at 12 months and those who do not with respect to the proportion of children in each group, with a satisfactory immune response at 19 months of age, measured by OPA to each of the 11 serotypes included in the PPS for which an OPA has been developed. The secondary objective is to assess the immunogenicity and impact on carriage of various Pnc vaccination regimens that combine 1 to 3 doses of PCV with a dose of PPS, concerns regarding the potential for the development of hyporesponsiveness. Endpoints to be evaluated will include serotype specific immunoglobulin G antibody measured by enzyme-linked immunosorbent assay to the 23 serotypes in the PPS, avidity assays to the same serotypes, opsonophagocytic assays to the 11 serotypes for which these assays are currently available, and Pnc carriage by serotype. With hyporesponsiveness as the primary endpoint of interest a scheme of analysis has been proposed which will require a minimum sample size of 500.
- Conditions
- Pneumococcal Infections
- Being tested
- Pneumovax 23, Prevnar
- Keywords
- Pneumococcal infections, Fiji, infants, vaccine
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumovax 23Biological
23-valent PPS, 25 micrograms/serotype
PrevnarBiological
7-valent PCV, 2 micrograms/serotype, except serotype 6B which is 4 micrograms/serotype
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | PCV at 6 weeks, 10 weeks, and 14 weeks; PPS at 18 months Receives: Biological: Pneumovax 23; Biological: Prevnar |
| B | Experimental | PCV at 6 weeks, 10 weeks, and 14 weeks; PPS at 12 months and 18 months Receives: Biological: Pneumovax 23; Biological: Prevnar |
| C | Experimental | PCV at 6 weeks and 14 weeks; PPS at 18 months Receives: Biological: Pneumovax 23; Biological: Prevnar |
| D | Experimental | PCV at 6 weeks and 14 weeks; PPS at 12 months and 18 months Receives: Biological: Pneumovax 23; Biological: Prevnar |
| E | Experimental | PCV at 14 weeks; PPS at 18 months Receives: Biological: Pneumovax 23; Biological: Prevnar |
| F | Experimental | PCV at 14 weeks; PPS at 12 months and 18 months Receives: Biological: Pneumovax 23; Biological: Prevnar |
| G | Experimental | No PCV; PPS at 12 months and 18 months Receives: Biological: Pneumovax 23 |
| H | Active comparator | No PCV; PPS at 18 months Receives: Biological: Pneumovax 23 |
What is being measured
The primary outcome is the main question the study is designed to answer.
For each serotype assayed (23 for ELISA and 11 for functional assays) the proportion of children responding to the micro-PPS dose at 18 months and the GMC of the response will be compared between children who receive PPS at 12 months and those who do not
Measured: 19 months of age
Secondary outcomes (3)
Proportion of children showing hyporesponse at 18 months to more than half of all 23 serotypes
Measured: 18 weeks; 12.5 months of age
Immunogenicity and carriage: Immune responses following the primary series of conjugate vaccination, measured by ELISA and OPA will be compared between the group receiving two doses of PCV and those receiving 3 doses of vaccine
Measured: 18 months of age
Rate of decline: assessment of antibody levels
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startNov 2005
- Primary completionJan 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pneumococcal InfectionsStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 552 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Investigators
- Fiona M Russell, FRACP, Principal investigator, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00170612
- Sponsor's protocol ID
- 03-042
- Other IDs
- FNRERC Reference # 2002-001
- Status last verified
- Oct 2008
- First submitted
- 13 Sep 2005
- Last updated
- 21 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Russell FM, Balloch A, Licciardi PV, Carapetis JR, Tikoduadua L, Waqatakirewa L, Cheung YB, Mulholland EK, Tang ML. Serotype-specific avidity is achieved following a single dose of the 7-valent pneumococcal conjugate vaccine, and is enhanced by 23-valent pneumococcal polysaccharide booster at 12 months. Vaccine. 2011 Jun 15;29(27):4499-506. doi: 10.1016/j.vaccine.2011.04.038. Epub 2011 May 1.
PubMed 21539882Russell FM, Carapetis JR, Burton RL, Lin J, Licciardi PV, Balloch A, Tikoduadua L, Waqatakirewa L, Cheung YB, Tang ML, Nahm MH, Mulholland EK. Opsonophagocytic activity following a reduced dose 7-valent pneumococcal conjugate vaccine infant primary series and 23-valent pneumococcal polysaccharide vaccine at 12 months of age. Vaccine. 2011 Jan 10;29(3):535-44. doi: 10.1016/j.vaccine.2010.10.046. Epub 2010 Oct 31.
PubMed 21044669Russell FM, Carapetis JR, Satzke C, Tikoduadua L, Waqatakirewa L, Chandra R, Seduadua A, Oftadeh S, Cheung YB, Gilbert GL, Mulholland EK. Pneumococcal nasopharyngeal carriage following reduced doses of a 7-valent pneumococcal conjugate vaccine and a 23-valent pneumococcal polysaccharide vaccine booster. Clin Vaccine Immunol. 2010 Dec;17(12):1970-6. doi: 10.1128/CVI.00117-10. Epub 2010 Oct 13.
PubMed 20943882Russell FM, Carapetis JR, Balloch A, Licciardi PV, Jenney AW, Tikoduadua L, Waqatakirewa L, Pryor J, Nelson J, Byrnes GB, Cheung YB, Tang ML, Mulholland EK. Hyporesponsiveness to re-challenge dose following pneumococcal polysaccharide vaccine at 12 months of age, a randomized controlled trial. Vaccine. 2010 Apr 26;28(19):3341-9. doi: 10.1016/j.vaccine.2010.02.087. Epub 2010 Mar 4.
PubMed 20206670Russell FM, Licciardi PV, Balloch A, Biaukula V, Tikoduadua L, Carapetis JR, Nelson J, Jenney AW, Waqatakirewa L, Colquhoun S, Cheung YB, Tang ML, Mulholland EK. Safety and immunogenicity of the 23-valent pneumococcal polysaccharide vaccine at 12 months of age, following one, two, or three doses of the 7-valent pneumococcal conjugate vaccine in infancy. Vaccine. 2010 Apr 19;28(18):3086-94. doi: 10.1016/j.vaccine.2010.02.065. Epub 2010 Mar 1.
PubMed 20199764
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Blind Open-Label Randomized Phase II Study of the Safety, Immunogenicity and Impact on Pneumococcus (Pnc) Carriage of the Pnc Vaccination Regimens Combining 1, 2, or 3 Doses of 7-Valent Pneumococcal Conjugate Vaccine (PCV) in the First 4 Months of Life Followed by a Single Dose of 23-Valent Pneumococcal Polysaccharide Vaccine (PPS) at 12 Months of Age
- ClinicalTrials.gov ID
- NCT00170612
- Acronym / sponsor ID
- 03-042
- Conditions
- Pneumococcal Infections
- Keywords
- Pneumococcal infections, Fiji, infants, vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 552 participants (actual)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Nov 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 15 Sep 2005 (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.
Pneumonia is the most common reason for admission of Fijian children to hospitals. The most common germ causing pneumonia is "streptococcus pneumoniae." It is a common cause of meningitis (infection around the brain and spinal cord), ear infections, and blood infections and it lives in the nose of humans. A vaccine has been developed that will help prevent these common diseases but prevents only about one quarter of pneumonia cases and it is expensive. This study explores new ways of giving this vaccine that are affordable, safe, and effective in countries such as Fiji. About 550 Fijian infants presenting at 6 weeks of age, for their first diptheria, tetanus, toxoid, pertussis vaccine immunization, to one of the participating Health Centers or Colonial War Memorial Hospital in urban Suva, Fiji will be enrolled. Children will remain in the study for 2 years. Study procedures include full vaccination against 7 types of pneumococcus, blood tests, and nasal swabs.
Detailed description
This research project began as a study of alternative strategies for Pnc (Pneumococcus) immunization for children in developing countries. In the original study, infants presenting to a health center in urban Fiji were randomized to receive 1, 2, or 3 doses of PCV (Prevnar) followed by a dose of 23-valent PPS (Pneumococcal polysaccharide vaccine) at 6 or 9 months of age. The regimens were compared with each other and with 2 control groups with respect to immunogenicity, impact on carriage of vaccine type Pnc, and response to a small dose of PPS at 15 months of age. After the trial was underway and 228 infants had been recruited, concerns were raised about the safety of PPS in infancy. Specifically concerns were raised that it might result in later immunological hyporesponsiveness in some of the recipients, to some of the serotypes. After a thorough review it was decided to proceed with the study, but to modify it so that it addressed directly the issue of potential hyporesponsiveness, while not giving PPS to any children under 12 months of age. This protocol represents the completion of the study with the new design for the children already enrolled, and a new design for a further cohort of children who will be enrolled. The newly designed trial will be a single blind, open-label, randomized, controlled trial of 550 healthy infants. Infants will be randomized to 1 of 8 equal groups to receive 0, 1, 2, or 3 doses of PCV (Pneumococcal conjugate vaccine), with or without a booster of PPS at 12 months of age. Two control groups will be recruited, 1 will receive no PCV in infancy and the other will receive a dose of PPS at 12 months of age. At 18 months of age, all infants will receive a 20 percent dose of PPS to stimulate and allow the assessment of immunological memory. At 2 years of age, any child who has received no or one dose of PCV (Groups E, F, G and H) will receive a single dose of PCV. Blood samples will be taken at 18 weeks age, 12 months of age, before the 18 months dose and 4 weeks later. In addition half of the children will have a blood sample taken at 9 months and the other half will have a sample taken 2 weeks after their 12 month dose of PPS. The 9- and 12-month blood sample will assess the long-term persistence of circulating antibody and avidity maturation following a 1, 2, or 3 dose primary series of PCV. The primary objective is to demonstrate noninferiority at 19 months of age, of those groups receiving PPS at 12 months and those who do not with respect to the proportion of children in each group, with a satisfactory immune response at 19 months of age, measured by OPA to each of the 11 serotypes included in the PPS for which an OPA has been developed. The secondary objective is to assess the immunogenicity and impact on carriage of various Pnc vaccination regimens that combine 1 to 3 doses of PCV with a dose of PPS, concerns regarding the potential for the development of hyporesponsiveness. Endpoints to be evaluated will include serotype specific immunoglobulin G antibody measured by enzyme-linked immunosorbent assay to the 23 serotypes in the PPS, avidity assays to the same serotypes, opsonophagocytic assays to the 11 serotypes for which these assays are currently available, and Pnc carriage by serotype. With hyporesponsiveness as the primary endpoint of interest a scheme of analysis has been proposed which will require a minimum sample size of 500.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Biological: Pneumovax 23, Biological: PrevnarPCV at 6 weeks, 10 weeks, and 14 weeks; PPS at 18 months |
| B | Experimental | Biological: Pneumovax 23, Biological: PrevnarPCV at 6 weeks, 10 weeks, and 14 weeks; PPS at 12 months and 18 months |
| C | Experimental | Biological: Pneumovax 23, Biological: PrevnarPCV at 6 weeks and 14 weeks; PPS at 18 months |
| D | Experimental | Biological: Pneumovax 23, Biological: PrevnarPCV at 6 weeks and 14 weeks; PPS at 12 months and 18 months |
| E | Experimental | Biological: Pneumovax 23, Biological: PrevnarPCV at 14 weeks; PPS at 18 months |
| F | Experimental | Biological: Pneumovax 23, Biological: PrevnarPCV at 14 weeks; PPS at 12 months and 18 months |
| G | Experimental | Biological: Pneumovax 23No PCV; PPS at 12 months and 18 months |
| H | Active comparator | Biological: Pneumovax 23No PCV; PPS at 18 months |
Who may qualify
- Ages
- 6 to 8 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy infant aged between 6 and 8 weeks
- No significant maternal or perinatal history
- Written and signed parental/caregiver consent
- Lives within 30 minutes of the health clinic
- Family anticipate living in the study area for the next 2 years
Key exclusion criteria (12 listed)
- Known allergy to any component of the vaccine
- Allergic reaction or anaphylactoid reaction with previous vaccines
- Known immunodeficiency disorder
- HIV positive mother (many women are tested for HIV antenatally, however a test is not planned; therefore it would be based on clinic records or self report)
- Known thrombocytopenia or coagulation disorder
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 |
|---|---|---|
| Pneumovax 2323-valent PPS, 25 micrograms/serotype | Biological | A, B, C, D, E, F, G, H |
| Prevnar7-valent PCV, 2 micrograms/serotype, except serotype 6B which is 4 micrograms/serotype | Biological | A, B, C, D, E, F |
Primary outcome
For each serotype assayed (23 for ELISA and 11 for functional assays) the proportion of children responding to the micro-PPS dose at 18 months and the GMC of the response will be compared between children who receive PPS at 12 months and those who do not
Time frame: 19 months of age
3 secondary outcomes
Proportion of children showing hyporesponse at 18 months to more than half of all 23 serotypes
Time frame: 18 weeks; 12.5 months of age
Immunogenicity and carriage: Immune responses following the primary series of conjugate vaccination, measured by ELISA and OPA will be compared between the group receiving two doses of PCV and those receiving 3 doses of vaccine
Time frame: 18 months of age
Rate of decline: assessment of antibody levels
Time frame: 12 months
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 21 Oct 2008.
- Derived from this study: PubMed 21539882Russell FM, Balloch A, Licciardi PV, Carapetis JR, Tikoduadua L, Waqatakirewa L, Cheung YB, Mulholland EK, Tang ML. Serotype-specific avidity is achieved following a single dose of the 7-valent pneumococcal conjugate vaccine, and is enhanced by 23-valent pneumococcal polysaccharide booster at 12 months. Vaccine. 2011 Jun 15;29(27):4499-506. doi: 10.1016/j.vaccine.2011.04.038. Epub 2011 May 1.
- Derived from this study: PubMed 21044669Russell FM, Carapetis JR, Burton RL, Lin J, Licciardi PV, Balloch A, Tikoduadua L, Waqatakirewa L, Cheung YB, Tang ML, Nahm MH, Mulholland EK. Opsonophagocytic activity following a reduced dose 7-valent pneumococcal conjugate vaccine infant primary series and 23-valent pneumococcal polysaccharide vaccine at 12 months of age. Vaccine. 2011 Jan 10;29(3):535-44. doi: 10.1016/j.vaccine.2010.10.046. Epub 2010 Oct 31.
- Derived from this study: PubMed 20943882Russell FM, Carapetis JR, Satzke C, Tikoduadua L, Waqatakirewa L, Chandra R, Seduadua A, Oftadeh S, Cheung YB, Gilbert GL, Mulholland EK. Pneumococcal nasopharyngeal carriage following reduced doses of a 7-valent pneumococcal conjugate vaccine and a 23-valent pneumococcal polysaccharide vaccine booster. Clin Vaccine Immunol. 2010 Dec;17(12):1970-6. doi: 10.1128/CVI.00117-10. Epub 2010 Oct 13.
- Derived from this study: PubMed 20206670Russell FM, Carapetis JR, Balloch A, Licciardi PV, Jenney AW, Tikoduadua L, Waqatakirewa L, Pryor J, Nelson J, Byrnes GB, Cheung YB, Tang ML, Mulholland EK. Hyporesponsiveness to re-challenge dose following pneumococcal polysaccharide vaccine at 12 months of age, a randomized controlled trial. Vaccine. 2010 Apr 26;28(19):3341-9. doi: 10.1016/j.vaccine.2010.02.087. Epub 2010 Mar 4.
- Derived from this study: PubMed 20199764Russell FM, Licciardi PV, Balloch A, Biaukula V, Tikoduadua L, Carapetis JR, Nelson J, Jenney AW, Waqatakirewa L, Colquhoun S, Cheung YB, Tang ML, Mulholland EK. Safety and immunogenicity of the 23-valent pneumococcal polysaccharide vaccine at 12 months of age, following one, two, or three doses of the 7-valent pneumococcal conjugate vaccine in infancy. Vaccine. 2010 Apr 19;28(18):3086-94. doi: 10.1016/j.vaccine.2010.02.065. Epub 2010 Mar 1.
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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.
Fiona M Russell, FRACP principal investigator
University of Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pneumovax 23 and Prevnar in people with Pneumococcal Infections, run by University of Melbourne at 1 site in Fiji.
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 12 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 21 Oct 2008. 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 Fiji. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
For each serotype assayed (23 for ELISA and 11 for functional assays) the proportion of children responding to the micro-PPS dose at 18 months and the GMC of the response will be compared between children who receive PPS at 12 months and those who do not (time frame: 19 months of age). 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 NCT00170612, which also lists 5 linked publications.
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 21 Oct 2008.