Vaccines, PneumococcalPhase 3NCT00444457
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine In Healthy Infants
A Phase 3 study testing 13-valent Pneumococcal Conjugate Vaccine and 7vPnC in people with Vaccines, Pneumococcal, run by Wyeth is now a wholly owned subsidiary of Pfizer at 78 sites in United States.
Trial summary
The purpose of this study will be to evaluate safety, tolerability and immunogenicity of three lots of 13-valent pneumococcal vaccine given to healthy infants. Lots will be studied for consistency of the immune response, as well as for non-inferiority and safety as compared to 7-valent Pneumococcal Conjugate Vaccine. Read more about this study
- Who is it for?
- Ages 42 to 98 daysHealthy volunteers can take part
- Conditions the study is for
- Vaccines, Pneumococcal
- What is being tested?
- 13-valent Pneumococcal Conjugate Vaccine and 7vPnC
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,712 participants
- Where
- 78 sitesUnited States
- Study dates
- May 2007to Jun 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 42 to 98 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy 2 month old infants
- Available for the duration of the study and reachable by telephone
- Able to complete two blood drawing procedures during the study
Who cannot join
- Previous vaccination, contraindication or history of allergic reaction to vaccines or vaccine components
- Bleeding disorder, immune deficiency or significant chronic or congenital disease
- Previous receipt of blood products or immune globulin
Trial locations and contacts
78 sites in 1 country.
78 sites in 1 country
United States78 sites
Study site
Atlanta, Georgia, 30322
Study site
Bardstown, Kentucky, 40004
Study site
Benton, Arkansas, 72019
Study site
Bismarck, North Dakota, 58501
Study site
Boston, Massachusetts, 02111
Study site
Boston, Massachusetts, 02116
Study site
Boulder, Colorado, 80303
Study site
Cary, North Carolina, 27518
Study site
Chicago, Illinois, 60647
Study site
Cincinnati, Ohio, 45245
Study site
Clarksville, Tennessee, 37043
Study site
Cleveland, Ohio, 44121
Study site
Conway, Arkansas, 72033
Study site
Crestview Hills, Kentucky, 41017
Study site
DeKalb, Illinois, 60115
Study site
Downey, California, 90242
Study site
Durham, North Carolina, 27704
Study site
Durham, North Carolina, 27705
Study site
Fall River, Massachusetts, 02124
Study site
Fargo, North Dakota, 58103
Study site
Fayetteville, Arkansas, 72703
Study site
Fishkill, New York, 12524
Study site
Fontana, California, 92335
Study site
Fountain Valley, California, 92708
Study site
Franklin, Tennessee, 37067
Study site
Galveston, Texas, 77555
Study site
Hopewell Jct, New York, 12533
Study site
Huber Heights, Ohio, 45424
Study site
Ithaca, New York, 14850
Study site
Jackson, Mississippi, 39216
Study site
Jackson, Tennessee, 38305
Study site
Jamaica Plain, Massachusetts, 02130
Study site
Jonesboro, Arkansas, 72401
Study site
Kettering, Ohio, 45429
Study site
Kingsport, Tennessee, 37660
Study site
Kittanning, Pennsylvania, 16201
Study site
La Crosse, Wisconsin, 54601
Study site
Lakewood, California, 90805
Study site
Latrobe, Pennsylvania, 15650
Study site
Layton, Utah, 84041
Study site
Lebanon, New Hampshire, 03756
Study site
Little Rock, Arkansas, 72205
Study site
Loma Linda, California, 92354
Study site
Longmont, Colorado, 80501
Study site
Louisville, Kentucky, 40202
Study site
Louisville, Kentucky, 40207
Study site
Marietta, Georgia, 30062
Study site
Marshfield, Wisconsin, 54449
Study site
Mason, Ohio, 45040
Study site
Monroe, Wisconsin, 53566
Study site
Moreno Valley, California, 92557
Study site
Murray, Utah, 84107
Study site
Nampa, Idaho, 83686
Study site
North Little Rock, Arkansas, 72117
Study site
Norwich, Connecticut, 06360
Study site
Omaha, Nebraska, 68127
Study site
Omaha, Nebraska, 68131
Study site
Palm Beach Gardens, Florida, 33410
Study site
Paramount, California, 90723
Study site
Pittsburgh, Pennsylvania, 15227
Study site
Pittsburgh, Pennsylvania, 15236
Study site
Pittsburgh, Pennsylvania, 15241
Study site
Riverside, California, 92505
Study site
Rolling Hills Estates, California, 90274
Study site
San Antonio, Texas, 78212
Study site
South Jordan, Utah, 84095
Study site
St Louis, Missouri, 63110
Study site
Sylva, North Carolina, 28779
Study site
Syracuse, New York, 13202
Study site
Tampa, Florida, 33606
Study site
The Bronx, New York, 10467
Study site
Tulsa, Oklahoma, 74127
Study site
Vancouver, Washington, 98664
Study site
Vancouver, Washington, 98684
Study site
Vancouver, Washington, 98686
Study site
Vienna, Virginia, 22180
Study site
Whitehouse Station, New Jersey, 08809
Study site
Woodstock, Georgia, 30189
About this study
Official title: A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of Three Lots of 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in the United States
The purpose of this study will be to evaluate safety, tolerability and immunogenicity of three lots of 13-valent pneumococcal vaccine given to healthy infants. Lots will be studied for consistency of the immune response, as well as for non-inferiority and safety as compared to 7-valent Pneumococcal Conjugate Vaccine.
- Conditions
- Vaccines, Pneumococcal
- Being tested
- 13-valent Pneumococcal Conjugate Vaccine, 7vPnC
- Keywords
- Vaccine, Infants, Pneumococcal Conjugate Vaccines, Vaccines, Pneumococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
13-valent Pneumococcal Conjugate VaccineBiological
0.5 mL of study vaccine administered IM at 2, 4, 6, and 12 months of age.
7vPnCBiological
0.5 mL of study vaccine administered IM at 2, 4, 6, and 12 months of age.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: 13-valent Pneumococcal Conjugate Vaccine |
| 2 | Experimental | Not described Receives: Biological: 13-valent Pneumococcal Conjugate Vaccine |
| 3 | Experimental | Not described Receives: Biological: 13-valent Pneumococcal Conjugate Vaccine |
| 4 | Active comparator | Not described Receives: Biological: 7vPnC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series
Antibody geometric mean concentration (GMC) as measured by micrograms per milliliter (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
Measured: 1 Month after the infant series (7 Months of age)
Percentage of Participants Achieving Predefined Antibody Level ≥0.1 International Units Per Milliliter (IU/mL) for Tetanus Toxoid in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series
Percentage of participants achieving predefined antibody threshold ≥0.1 IU/ mL along with the corresponding 95% CI for concomitant antigen tetanus toxoid are presented. Exact 2-sided CI was based on the observed proportion of participants. Combined 13vPnC group includes participants randomized to pilot lot 1, pilot lot 2, or the manufacturing lot.
Measured: 1 month after the infant series (7 months of age)
Percentage of Participants Achieving Predefined Antibody Level ≥1:8 for Poliovirus in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series
Percentage of participants achieving predefined antibody threshold ≥1:8 along with the corresponding 95% CI for concomitant antigen poliovirus type 1, type 2, and type 3 (Sabin strains 1, 2, 3) are presented. Exact 2-sided CI was based on the observed proportion of participants. Combined 13vPnC group includes participants randomized to pilot lot 1, pilot lot 2, or the manufacturing lot.
Measured: 1 month after the infant series (7 months of age)
Percentage of Participants Achieving Predefined Antibody Level ≥10.0 Milli-International Units Per Milliliter (mIU/mL) for Hepatitis B in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series
Percentage of participants achieving predefined antibody threshold ≥10.0 mIU/ mL along with the corresponding 95% CI for concomitant antigen hepatitis B are presented. Exact 2-sided CI was based on the observed proportion of participants. Combined 13vPnC group includes participants randomized to pilot lot 1, pilot lot 2, or the manufacturing lot.
Measured: 1 month after the infant series (7 months of age)
Secondary outcomes (5)
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series
Percentage of participants achieving predefined antibody threshold ≥0.35mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.
Measured: 1 month after the infant series (7 months of age)
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose
Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.
Measured: 1 month after the toddler dose (13 months of age)
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Combined 13vPnC Group 1 Month After the Infant Series
Percentage of participants achieving predefined antibody threshold ≥1.00 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.
Measured: 1 month after the infant series (7 months of age)
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose
Percentage of participants achieving predefined antibody threshold ≥1.00 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.
Measured: 1 month after the toddler dose (13 months of age)
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose
Antibody geometric mean concentration (GMC) as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
Measured: 1 month after the toddler dose (13 months of age)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2007 (estimated)
- Study startMay 2007
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vaccines, PneumococcalStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,712 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00444457
- Sponsor's protocol ID
- 6096A1-3005
- Status last verified
- Oct 2012
- First submitted
- 5 Mar 2007
- Last updated
- 15 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Payton T, Girgenti D, Frenck RW, Patterson S, Love J, Razmpour A, Sidhu MS, Emini EA, Gruber WC, Scott DA. Immunogenicity, safety and tolerability of 3 lots of 13-valent pneumococcal conjugate vaccine given with routine pediatric vaccinations in the United States. Pediatr Infect Dis J. 2013 Aug;32(8):871-80. doi: 10.1097/INF.0b013e3182906499.
PubMed 23584582Bryant KA, Gurtman A, Girgenti D, Reisinger K, Johnson A, Pride MW, Patterson S, Devlin C, Gruber WC, Emini EA, Scott DA. Antibody responses to routine pediatric vaccines administered with 13-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2013 Apr;32(4):383-8. doi: 10.1097/INF.0b013e318279e9a9.
PubMed 23104129
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of Three Lots of 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in the United States
- ClinicalTrials.gov ID
- NCT00444457
- Acronym / sponsor ID
- 6096A1-3005
- Conditions
- Vaccines, Pneumococcal
- Keywords
- Vaccine, Infants, Pneumococcal Conjugate Vaccines, Vaccines, Pneumococcal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,712 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 7 Mar 2007 (estimated)
- Results
- Posted 14 Jul 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study will be to evaluate safety, tolerability and immunogenicity of three lots of 13-valent pneumococcal vaccine given to healthy infants. Lots will be studied for consistency of the immune response, as well as for non-inferiority and safety as compared to 7-valent Pneumococcal Conjugate Vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: 13-valent Pneumococcal Conjugate Vaccine |
| 2 | Experimental | Biological: 13-valent Pneumococcal Conjugate Vaccine |
| 3 | Experimental | Biological: 13-valent Pneumococcal Conjugate Vaccine |
| 4 | Active comparator | Biological: 7vPnC |
Who may qualify
- Ages
- 42 to 98 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy 2 month old infants
- Available for the duration of the study and reachable by telephone
- Able to complete two blood drawing procedures during the study
Key exclusion criteria (3 listed)
- Previous vaccination, contraindication or history of allergic reaction to vaccines or vaccine components
- Bleeding disorder, immune deficiency or significant chronic or congenital disease
- Previous receipt of blood products or immune globulin
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 |
|---|---|---|
| 13-valent Pneumococcal Conjugate Vaccine0.5 mL of study vaccine administered IM at 2, 4, 6, and 12 months of age. | Biological | 1, 2, 3 |
| 7vPnC0.5 mL of study vaccine administered IM at 2, 4, 6, and 12 months of age. | Biological | 4 |
Primary outcome
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series
Time frame: 1 Month after the infant series (7 Months of age)
Antibody geometric mean concentration (GMC) as measured by micrograms per milliliter (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
Percentage of Participants Achieving Predefined Antibody Level ≥0.1 International Units Per Milliliter (IU/mL) for Tetanus Toxoid in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series
Time frame: 1 month after the infant series (7 months of age)
Percentage of participants achieving predefined antibody threshold ≥0.1 IU/ mL along with the corresponding 95% CI for concomitant antigen tetanus toxoid are presented. Exact 2-sided CI was based on the observed proportion of participants. Combined 13vPnC group includes participants randomized to pilot lot 1, pilot lot 2, or the manufacturing lot.
Percentage of Participants Achieving Predefined Antibody Level ≥1:8 for Poliovirus in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series
Time frame: 1 month after the infant series (7 months of age)
Percentage of participants achieving predefined antibody threshold ≥1:8 along with the corresponding 95% CI for concomitant antigen poliovirus type 1, type 2, and type 3 (Sabin strains 1, 2, 3) are presented. Exact 2-sided CI was based on the observed proportion of participants. Combined 13vPnC group includes participants randomized to pilot lot 1, pilot lot 2, or the manufacturing lot.
Percentage of Participants Achieving Predefined Antibody Level ≥10.0 Milli-International Units Per Milliliter (mIU/mL) for Hepatitis B in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series
Time frame: 1 month after the infant series (7 months of age)
Percentage of participants achieving predefined antibody threshold ≥10.0 mIU/ mL along with the corresponding 95% CI for concomitant antigen hepatitis B are presented. Exact 2-sided CI was based on the observed proportion of participants. Combined 13vPnC group includes participants randomized to pilot lot 1, pilot lot 2, or the manufacturing lot.
5 secondary outcomes
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series
Time frame: 1 month after the infant series (7 months of age)
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose
Time frame: 1 month after the toddler dose (13 months of age)
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Combined 13vPnC Group 1 Month After the Infant Series
Time frame: 1 month after the infant series (7 months of age)
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose
Time frame: 1 month after the toddler dose (13 months of age)
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose
Time frame: 1 month after the toddler dose (13 months of age)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23584582Payton T, Girgenti D, Frenck RW, Patterson S, Love J, Razmpour A, Sidhu MS, Emini EA, Gruber WC, Scott DA. Immunogenicity, safety and tolerability of 3 lots of 13-valent pneumococcal conjugate vaccine given with routine pediatric vaccinations in the United States. Pediatr Infect Dis J. 2013 Aug;32(8):871-80. doi: 10.1097/INF.0b013e3182906499.
- Derived from this study: PubMed 23104129Bryant KA, Gurtman A, Girgenti D, Reisinger K, Johnson A, Pride MW, Patterson S, Devlin C, Gruber WC, Emini EA, Scott DA. Antibody responses to routine pediatric vaccines administered with 13-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2013 Apr;32(4):383-8. doi: 10.1097/INF.0b013e318279e9a9.
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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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
78 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 13-valent Pneumococcal Conjugate Vaccine and 7vPnC in people with Vaccines, Pneumococcal, run by Wyeth is now a wholly owned subsidiary of Pfizer at 78 sites in United States.
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 3 inclusion and 3 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 15 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 78 sites in United States. 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 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?
Yes. Results are posted in the registry (first posted 14 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series (time frame: 1 Month after the infant series (7 Months of age)). The study lists 4 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 NCT00444457, which also lists 2 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 15 Oct 2012.