Correction

Article title: Efficacy of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine against acute otitis media and nasopharyngeal carriage in Panamanian children – A randomized controlled trial

Authors: Xavier Saez Llorens, Stella Rowley, Digna Wong, Mirna Rodriguez, Arlene Calvo, Marisol Troitino, Albino Salas, Vielka Vega, Maria Mercedes Castrejon,

Patricia Lommel, Thierry G. Pascal, William P Hausdorff, Dorota Borys, Javier Ruiz-Guinazu, Eduardo Ortega Barrio, Juan Pablo Yarzabal, Lode Schuerman

Journal: Human Vaccines & Immunotherapeutics

Bibliometrics: Volume 13, Number 6, pages 1213-1228

DOI: http://dx.doi.org/10.1080/21645515.2017.1287640

This article originally published with an error in the results section (Nasopharyngeal carriage cohorts), as well as errors in tables 3 and tables 4 and an incorrect reference citation in the title of table 5. These errors do not affect the conclusion of the paper.

Table 3.

Subanalyses of vaccine efficacy (VE) against C-AOM: by age, pre-/post-booster vaccination, episode severity and by sex (intent-to-treat analysis)

	First C-AOM episodes								All C-AOM episodesa
	Number of children		Follow-up time, person-yearsb		Incidence, per 100,000 person-years			VE against first episodes, % (95% CI)	Number of episodes		Follow-up time, person-yearsc		Incidence, per 100,000 person-years		VE against all episodes, % (95% CI)
Group	PHiD-CV	Control	PHiD-CV	Control	PHiD-CV	Control			PHiD-CV	Control	PHiD-CV	Control	PHiD-CV	Control
Total	254	308	9018.3	8835.1	2816.5	3486.1		19.0 (4.4, 31.4)	294	343	9475.3	9412.8	3102.8	3644.0	14.8 (-1.0, 28.2)
AOM by sexd
Females	119	140	4370.0	4329.6	2723.1	3233.6		15.9 (-7.4, 34.1)	139	150	4589.7	4590.5	3028.5	3267.6	7.6 (-18.4, 27.6)
Male	135	168	4648.3	4505.5	2904.3	3728.8		21.7 (1.8; 37.6)	155	193	4885.6	4822.3	3172.6	4002.2	20.5 (-0.3, 37.1)
Age
2–11 months	104	141	2786.8	2762.3	3731.9	5104.4		26.9 (5.9, 43.3)	115	150	2824.7	2812.6	4071.2	5333.1	23.7 (1.3, 41.0)
12–23 months	99	122	3023.8	2956.5	3274.0	4126.5		19.7 (-4.7, 38.4)	114	135	3176.7	3155.2	3588.6	4278.7	16.1 (-8.1, 34.8)
<24 months	203	263	5810.6	5718.8	3493.6	4598.9		24.0 (8.7, 36.7)	229	285	6001.4	5967.8	3815.8	4775.6	20.1 (3.8, 33.6)
24–35 months	47	42	2474.3	2390.8	1899.6	1756.7		-10.5 (-67.5, 27.1)	60	54	2670.3	2636.2	2246.9	2048.4	-9.7 (-60.4, 25.0)
≥36 months	4	3	733.4	725.4	545.4	413.6		-33.8 (-497.7, 70.1)	5	4	803.6	808.8	622.2	494.6	-25.3 (-366.5, 66.4)
Pre-/post-booster
Pre-booster	124	177	3967.5	3925.8	3125.4	4508.6		30.7 (12.9, 44.9)	140	191	4050.2	4039.4	3456.6	4728.4	27.0 (7.8, 42.2)
Post-booster	132	123	5050.8	4909.2	2613.4	2505.5		-6.7 (-36.4, 16.6)	140	128	5425.1	5373.4	2580.6	2382.1	-8.5 (-39.0, 15.4)
AOM severity: complete reporting of all symptomse
Mild	119	120	9278.7	9202.6	1282.5	1304.0		1.7 (-26.7, 23.7)	127	127	9475.3	9412.8	1340.3	1349.2	0.7 (-28.5, 23.2)
Moderate	109	131	9269.9	9156.6	1175.8	1430.7		17.7 (-6.1, 36.2)	114	137	9475.3	9412.8	1203.1	1455.5	17.3 (-6.9, 36.0)
Severe	19	28	9439.5	9359.0	201.3	299.2		32.7 (-20.5, 62.4)	19	28	9475.3	9412.8	200.5	297.5	32.6 (-20.4, 62.3)
AOM severity: including incomplete reporting of symptoms (≥1 symptom)f
Mild	158	178	9198.1	9091.3	1717.8	1957.9	12.2 (-8.8, 29.1)		175	191	9475.3	9412.8	1846.9	2029.2	9.0 (-13.2, 26.8)
Moderate	126	146	9237.0	9135.0	1364.1	1598.3	14.7 (-8.3, 32.8)		133	154	9475.3	9412.8	1403.6	1636.1	14.2 (-9.2, 32.5)
Severe	22	28	9434.9	9359.0	233.2	299.2	22.1 (-36.1, 55.4)		22	28	9475.3	9412.8	232.2	297.5	22.0 (-36.0, 55.3)

AOM, acute otitis media; C-AOM, clinically-confirmed AOM; CI, confidence interval; post-booster, at the time of or after booster vaccination; intent-to-treat analysis, follow-up starting at the time of first vaccination. Vaccine efficacy was calculated as (1 – hazard ratio) x 100 using a Cox (first episodes) or generalized Cox (all episodes) regression model.

^aAll C-AOM episodes, including multiple episodes in the same child.

^bFollow-up time for first episodes calculated as sum of follow-up periods of each child, censored at the first occurrence of a respective endpoint event.

^cFollow-up time for all episodes calculated as sum of follow-up periods of each child, from dose 1 up to end of follow-up.

^dPost-hoc analysis

^eC-AOM episodes with complete reporting of information for all 5 symptoms (~80% of all reported C-AOM cases) on the clinical/otologic scale developed by Dagan et al.³³

^fC-AOM episodes with information for at least 1 symptom on the clinical/otologic scale developed by Dagan et al.³³; unrecorded symptoms were assumed not to be present in the patient.

Table 4.

Vaccine efficacy (VE) against B-AOM by age and pre-/post-booster vaccination (intent-to-treat cohort)

	First B-AOM episodes							All B-AOM episodesa
	Number of children with ≥1 episode		Follow-up time, person-years		Incidence, per 100,000 person-years		VE against first episodes, % (95% CI)	Number of episodes		Follow-up time, person-years		Incidence, per 100,000 person-years		VE against all episodes, % (95% CI)
Group	PHiD-CV	Control	PHiD-CV	Control	PHiD-CV	Control		PHiD-CV	Con-trol	PHiD-CV	Control	PHiD-CV	Control
Total	45	67	9396.9	9271.0	478.9	722.7	33.6 (3.2, 54.5)	47	70	9475.3	9412.8	496.0	743.7	33.3 (2.26, 54.5)
Age
2–11 months	20	35	2817.7	2798.3	709.8	1250.8	43.3 (1.7, 67.3)	21	35	2824.7	2812.6	743.4	1244.4	40.3 (-4.0, 65.7)
12–23 months	12	26	3150.1	3105.2	380.9	837.3	54.2 (9.3, 76.9)	13	27	3176.7	3155.2	409.2	855.7	52.1 (6.7, 75.5)
<24 months	32	61	5967.8	5903.5	536.2	1033.3	48.0 (20.3, 66.1)	34	62	6001.4	5967.8	566.5	1038.9	45.4 (15.8, 64.6)
24–35 months	13	6	2637.5	2578.6	492.9	232.7	-114.0 (-463.0, 18.7)	13	7	2670.3	2636.2	486.8	265.5	-83.3 (-359.1, 26.8)
≥36 months	0	0	791.5	788.9	0.0	0.0	U	0	1	803.6	808.8	0.0	123.6	100 (-3774.3, 100)
Pre-/post-booster
Pre-booster	24	47	4033.0	4007.9	595.1	1172.7	49.3 (17.1, 69.0)	26	48	4050.2	4039.4	641.9	1188.3	46.0 (10.9, 67.3)
Post-booster	19	20	5363.8	5263.2	354.2	380.0	6.0 (-76.2, 49.8)	19	20	5425.1	5373.4	350.2	372.2	5.8 (-76.0, 49.6)

AOM, acute otitis media; B-AOM, bacteriologically-confirmed AOM; CI, confidence interval; post-booster, at the time of or after booster vaccination; U, undefined; intent-to-treat analysis, follow-up starting at the time of first vaccination; per-protocol analysis, follow-up starting 2 weeks post-dose 3. Vaccine efficacy was calculated as (1 – hazard ratio) x 100 using a Cox (first episodes) or generalized Cox (all episodes) regression model.

^aAll B-AOM episodes, including recurrent episodes in the same child.

The sentence in the results section has been updated from “The number of children from whom nasopharyngeal swabs were taken ranged from … ” to the correct sentence of “The number of children that completed the nasopharyngeal sampling visit ranged from … ”

Below, tables 3 and tables 4 are reproduced in their corrected form. The errors in the results section and all tables have been corrected in the online version.